| 1 |
NCT02661646 |
Recruiting |
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced PCD |
|
- Device: Advanced Pneumatic Compression Device
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Quality of life
- Symptom changes
- Limb circumference changes after 12 weeks of treatment
- (and 4 more...)
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02661646 |
5010 |
|
December 2015 |
December 2018 |
December 2019 |
January 22, 2016 |
November 7, 2017 |
|
- VA NY Harbor Healthcare System - Brooklyn
Brooklyn, New York, United States - VA NY Harbor Healthcare System - St. Albans
Jamaica, New York, United States - VA NY Harbor Healthcare System - Manhattan
New York, New York, United States
|
| 2 |
NCT03465930 |
Recruiting |
Histologic Analysis of the Lymphatic Vessels Used for Supermicrosurgical Lymphatico-venous Anastomoses in Lymphedema |
|
- Procedure: Supermicrosurgical lymphatico-venous anastomoses
|
Observational |
|
- Paolo Gennaro
- Elisabetta Weber, MD
- University of Siena
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Expression of the lymphatic endothelial marker D2-40 in relation with the duration of lymphedema.
- Area of the vessel wall versus area of the lumen
- The relative proportion of smooth muscle cells and collagen fibers in the lymphatic vessel wall.
- (and 3 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03465930 |
LVA2017 |
s-LVA |
June 1, 2017 |
December 31, 2018 |
December 31, 2023 |
March 15, 2018 |
March 15, 2018 |
|
- Dept. of Maxillofacial Surgery, Azienda Ospedaliera Universitaria Senese
Siena, Italy
|
| 3 |
NCT02528539 |
Recruiting |
Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP) |
|
|
Interventional |
Not Applicable |
- Huntington Memorial Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Bioimpedance (L-dex U400)
- Arm circumference measurements of the upper limbs using at 4 cm interval
- Self-Efficacy Scale
- (and 3 more...)
|
30 |
Female |
18 Years and older (Adult, Senior) |
NCT02528539 |
HMH2015.002 |
|
August 2013 |
December 2017 |
December 2018 |
August 19, 2015 |
September 21, 2016 |
|
- Huntington Memorial Hospital
Pasadena, California, United States
|
| 4 |
NCT03428581 |
Not yet recruiting |
Preventing Lymphedema in Axillary Lymph Node Dissection |
|
- Procedure: ALND with ARM +/- LVB
- Procedure: ALND
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
- Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
|
264 |
Female |
18 Years and older (Adult, Senior) |
NCT03428581 |
16-010491 |
|
April 1, 2018 |
February 1, 2021 |
February 1, 2023 |
February 9, 2018 |
February 9, 2018 |
|
- Mayo Clinic in Florida
Jacksonville, Florida, United States - Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 5 |
NCT02167659 |
Recruiting |
Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT) |
|
- Device: 23-32 mmHg compression sleeve with gauntlet
|
Interventional |
Not Applicable |
- ImpediMed Limited
- Vanderbilt University
- Macquarie University, Australia
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Rate of progression of lymphedema
- Number of participants with risk factors associated with lymphedema.
- Time elapsed between identification of increasing fluid and referral out of study for continued swelling.
- Number of participants with improved skin condition, symptoms and quality of life.
|
1100 |
All |
18 Years and older (Adult, Senior) |
NCT02167659 |
VICCBRE1438 |
|
June 2014 |
December 2020 |
December 2020 |
June 19, 2014 |
February 16, 2018 |
|
- Mayo Clinic
Jacksonville, Florida, United States - University of Kansas Medical Center
Kansas City, Kansas, United States - University of Louisville
Louisville, Kentucky, United States - (and 7 more...)
|
| 6 |
NCT02949726 |
Recruiting |
Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development |
|
- Drug: Indocyanine Green (ICG)
- Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
|
Interventional |
Phase 1 |
- The University of Texas Health Science Center, Houston
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Lymphatic propulsive velocity as assessed by NIRFLI
- Lymphatic propulsive frequency as assessed by NIRFLI
- Percent extravascular dye as assessed by NIRFLI
- (and 5 more...)
|
100 |
Female |
18 Years and older (Adult, Senior) |
NCT02949726 |
HSC-MS-15-1021
1R01CA201487-01A1 |
|
April 24, 2017 |
April 2021 |
April 2021 |
October 31, 2016 |
May 4, 2017 |
|
- The University of Texas Health Science Center at Houston
Houston, Texas, United States
|
| 7 |
NCT03248310 |
Recruiting |
A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management |
|
- Behavioral: Quality of Life Assessments
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
300 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03248310 |
17-377 |
|
August 9, 2017 |
August 2022 |
August 2022 |
August 14, 2017 |
March 16, 2018 |
|
- Memorial Sloan Kettering Westchester
Harrison, New York, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 8 |
NCT01239160 |
Recruiting |
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema |
|
- Device: Flexitouch System
- Device: Hydroven FPR
|
Interventional |
Not Applicable |
- Centre for Research & Implementation of Clinical Practice
- Tactile Systems Technology, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- limb volume change after 12 weeks of treatment
- Adverse events
|
262 |
All |
18 Years and older (Adult, Senior) |
NCT01239160 |
Flexitouch 1010 |
ACE |
November 2010 |
December 2018 |
July 2019 |
November 11, 2010 |
January 26, 2018 |
|
- Hope Research Institute
Phoenix, Arizona, United States - Northwestern University
Chicago, Illinois, United States - Prairie Education & Research Cooperative
Springfield, Illinois, United States - (and 15 more...)
|
| 9 |
NCT02790021 |
Not yet recruiting |
Lymphaticovenous Anastomosis for Breast Cancer-related Lymphedema |
|
- Procedure: Lymphaticovenous anastomosis (LVA)
|
Interventional |
Not Applicable |
- Maastricht University Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Relative arm volume of the affected compared to the unaffected arm
- Change in quality of life after treatment using the EQ-5D-5L questionnaire
- Change in quality of life after treatment using the EORTC QLQ-C30 questionnaire
- (and 4 more...)
|
60 |
Female |
18 Years to 99 Years (Adult, Senior) |
NCT02790021 |
NL56477.068.16 |
|
July 2018 |
May 2019 |
September 2019 |
June 3, 2016 |
August 29, 2017 |
|
|
| 10 |
NCT02981485 |
Recruiting |
Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China |
|
|
Interventional |
Phase 2 |
- Peking Union Medical College
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in arm volume
- Change in tissue edema
- The function of the lymphatic vessel
- (and 2 more...)
|
30 |
Female |
20 Years to 60 Years (Adult) |
NCT02981485 |
CZ2015009 |
FGTBRCL |
December 2016 |
January 2018 |
January 2019 |
December 5, 2016 |
December 6, 2016 |
|
- Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
Shijingshan, Beijing, China
|
| 11 |
NCT02988479 |
Recruiting |
Out-of Pocket Payments in Patients With Lymphedema |
|
- Other: Out of pocket payments in patients
|
Observational |
|
- University Hospital, Montpellier
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
|
150 |
All |
6 Years to 80 Years (Child, Adult, Senior) |
NCT02988479 |
9638 |
Lymphorac2 |
July 2016 |
January 2017 |
June 2017 |
December 9, 2016 |
December 9, 2016 |
|
- University Hospital
Montpellier, France
|
| 12 |
NCT01521741 |
Recruiting |
Prospective Analysis of Symptoms and Lymphedema in Patients Following Treatment for Breast Cancer |
|
|
Observational |
|
- Massachusetts General Hospital
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Upper extremity changes following treatment for breast cancer
|
2500 |
Female |
18 Years and older (Adult, Senior) |
NCT01521741 |
08-540
R01CA139118 |
|
August 2009 |
August 2019 |
December 2023 |
January 31, 2012 |
April 7, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 13 |
NCT03313999 |
Recruiting |
Measuring Skin Elasticity in Lymphedema Patients |
- Diagnoses Disease
- Lymphedema
|
- Device: Lymphedema Indentometer
|
Interventional |
Not Applicable |
- Beth Israel Deaconess Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
2000 |
All |
18 Years and older (Adult, Senior) |
NCT03313999 |
2017P-000378 |
|
February 18, 2018 |
December 2027 |
December 2027 |
October 19, 2017 |
March 8, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
| 14 |
NCT02595996 |
Recruiting |
Propranolol Dose Escalation in Lymphedema in Patients |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients that tolerated propranolol
- Number of patients with improved quality of life based on self-reported questionnaires
- Number of patients with decreased fluid retention by weight
- (and 2 more...)
|
20 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02595996 |
AAAP9262 |
|
June 7, 2017 |
December 2018 |
December 2018 |
November 4, 2015 |
July 21, 2017 |
|
- Columbia University
New York, New York, United States
|
| 15 |
NCT03080207 |
Recruiting |
Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema |
- Lower Extremity Lymphedema
|
- Other: PRP method
- Other: Complex Decongestive Physiotherapy
- Other: Low Level Laser
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Volume of edema
- Lower extremity muscle strength
- Range of motion
- (and 3 more...)
|
45 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03080207 |
TSA-2017-22398 |
|
January 17, 2017 |
August 1, 2017 |
January 1, 2018 |
March 15, 2017 |
March 15, 2017 |
|
- Istanbul University Faculty of Health Science
Istanbul, Turkey
|
| 16 |
NCT02031627 |
Recruiting |
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device |
- Lower Extremity Lymphoedema
- Leg Lymphoedema
|
- Device: pneumatic compression 1 hour per day
- Device: pneumatic compression - 2 hours per day
- Device: pneumatic compression - 4 hours per day
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Intra/extra cellular fluid changes
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02031627 |
4010 FlexDose |
|
December 2013 |
December 2018 |
January 2019 |
January 9, 2014 |
October 25, 2017 |
|
- Royal Derby Hospital
Derby, United Kingdom
|
| 17 |
NCT00984269 |
Recruiting |
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection |
|
- Procedure: Tourniquet Use
|
Interventional |
Not Applicable |
- OrthoCarolina Research Institute, Inc.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lymphedema 15% change from pre-post in girth
- Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
|
206 |
Female |
18 Years and older (Adult, Senior) |
NCT00984269 |
08-09-14B |
|
September 2009 |
December 2018 |
December 2018 |
September 25, 2009 |
September 14, 2017 |
|
- University of Michigan Medical School
Ann Arbor, Michigan, United States - OrthoCarolina
Charlotte, North Carolina, United States
|
| 18 |
NCT03292198 |
Not yet recruiting |
Subclinical Lymphedema Treatment Study |
- Breast Cancer-related Subclinical Lymphedema
|
- Other: 20-30 mmHg compression sleeve and gauntlet
- Other: Manual Lymphatic Drainage
|
Interventional |
Not Applicable |
- Mercy Research
- Mercy Foundation
- St. Louis Men's Group Against Cancer
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
267 |
Female |
18 Years and older (Adult, Senior) |
NCT03292198 |
1070741-1 |
SLT |
April 2018 |
April 2022 |
December 2022 |
September 25, 2017 |
March 27, 2018 |
|
|
| 19 |
NCT03492476 |
Recruiting
New |
Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema |
|
- Device: Circaid
- Device: Short-stretching Bandage (Reference treatment)
|
Interventional |
Not Applicable |
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Volume reduction of upper limb lymphatic edema D30
- Volume reduction of upper limb lymphatic edema D5
- Volume reduction of upper limb lymphatic edema D90
- (and 15 more...)
|
140 |
Female |
18 Years and older (Adult, Senior) |
NCT03492476 |
C1512 |
|
September 8, 2017 |
December 2018 |
March 2019 |
April 10, 2018 |
April 10, 2018 |
|
- Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France - Chu Saint Eloi
Montpellier, France - Ghr Mulhouse Sud Alsace
Mulhouse, France - Hopital Cognacq Jay
Paris, France
|
| 20 |
NCT02734979 |
Recruiting |
Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Lymph Node Transfer for Upper Extremity Lymphedema |
|
- Device: Biobridge and lymph node transfer
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Limb volume reduction
- Serial lymphoscintigraphy
- Bioimpedance spectroscopy
- (and 3 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02734979 |
37161 |
Biobridge |
April 2016 |
May 2019 |
January 2020 |
April 12, 2016 |
April 25, 2017 |
|
- Stanford University
Stanford, California, United States
|
| 21 |
NCT01336790 |
Recruiting |
International Lymphatic Disease and Lymphedema Registry |
|
|
Observational |
|
- Stanford University
- Feinstein Institute for Medical Research
|
Other |
- Observational Model: Case-Only
- Time Perspective: Other
|
- prevalence of lymphatic disease
- socioeconomic impact of lymphatic disease
|
5000 |
All |
Child, Adult, Senior |
NCT01336790 |
SU-04052011-7662
16384 |
|
March 2009 |
December 2024 |
December 2025 |
April 18, 2011 |
March 2, 2018 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
| 22 |
NCT02988505 |
Recruiting |
Out-of Pocket Payments With Lymphedema in France |
- Primary Lymphedema Secondary Lymphedema
|
|
Observational |
|
- University Hospital, Montpellier
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
|
500 |
All |
6 Years to 80 Years (Child, Adult, Senior) |
NCT02988505 |
UF 9401 |
Lymphorac |
September 2014 |
December 2016 |
December 2017 |
December 9, 2016 |
December 9, 2016 |
|
- Departement information Medicale CHU Montpellier
Montpellier, France
|
| 23 |
NCT03252145 |
Recruiting |
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device |
- Lymphedema, Secondary
- Lymphedema of Upper Limb
|
- Device: PhysioTouch
- Other: Manual Lymph Drainage (MLD)
|
Interventional |
Not Applicable |
- University of California, San Francisco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Recruitment rates
- Retention rates
- Limb volume
- (and 15 more...)
|
80 |
Female |
18 Years and older (Adult, Senior) |
NCT03252145 |
P0518095 |
|
October 18, 2017 |
December 30, 2019 |
December 30, 2019 |
August 17, 2017 |
February 7, 2018 |
|
- University of California San Francisco
San Francisco, California, United States
|
| 24 |
NCT03373474 |
Recruiting |
Warm Acupuncture for Breast Cancer Related Lymphedema |
|
- Other: local distribution points association
- Other: local-distal points association
- Other: exercise with compression sleeve
|
Interventional |
Not Applicable |
- Tianjin University of Traditional Chinese Medicine
- National Basic Research Program, China
- Tianjin Medical University Cancer Institute and Hospital
- (and 4 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Upper extremity circumference
- Upper extremity volume
- Skin hardness
- (and 4 more...)
|
108 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03373474 |
2014CB543202-02 |
|
January 20, 2018 |
May 2018 |
July 2018 |
December 14, 2017 |
February 9, 2018 |
|
- Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China
|
| 25 |
NCT02748746 |
Not yet recruiting |
Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery |
|
- Device: Bio Impedance Analysis Measurement
- Device: Tissue Dielectric Constant Measurement
|
Interventional |
Not Applicable |
- Abant Izzet Baysal University
- Tubitak
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Investigation of early detection of lymphedema after breast cancer surgery with Bio Electrical Impedance Analysis (BIA)
- Investigation of symptom related quality of life with LymQoL
|
60 |
Female |
18 Years to 65 Years (Adult) |
NCT02748746 |
AbantIBU |
BIA |
August 2018 |
May 2019 |
November 2019 |
April 22, 2016 |
February 26, 2018 |
|
- Abant Izzet Baysal University
Bolu, City Centre, Turkey
|
| 26 |
NCT02743858 |
Recruiting |
Lymphedema Surveillance Study |
|
- Other: Bilateral arm measurements
- Other: Body mass index (BMI)
- Behavioral: Quality of Life Questionnaire
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- number of incidences of lymphedema
|
700 |
Female |
18 Years and older (Adult, Senior) |
NCT02743858 |
16-220 |
|
April 2016 |
April 2018 |
April 2018 |
April 19, 2016 |
November 1, 2017 |
|
- Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - (and 3 more...)
|
| 27 |
NCT03333226 |
Recruiting |
Axillary Reverse Mapping (ARM) in Breast Cancer Surgery to Prevent Lymphedema. (ARMtrial) |
|
- Procedure: Axillary Reverse Mapping (ARM)
|
Interventional |
Not Applicable |
- University Hospital of Ferrara
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of Breast Cancer Related Lymphedema (BCRL) after Axillary Lymph Node Dissection (ALND)
- Incidence of Breast Cancer Related Lymphedema (BCRL) after Sentinel Lymph Node Biopsy (SLNB) alone
- Crossover between Sentinel Lymph Node (SLN) of the Breast and the ARM lymph node
- Lymphoscintigraphic sub-clinical modifications of arm lymphatic drainage after ALND
|
300 |
Female |
18 Years and older (Adult, Senior) |
NCT03333226 |
RF-2013-02358165 |
|
January 17, 2018 |
December 2020 |
December 2020 |
November 6, 2017 |
January 23, 2018 |
|
- Azienda Ospedaliero Universitaria S. Anna
Cona, Ferrara, Italy
|
| 28 |
NCT02676752 |
Recruiting |
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis |
|
- Procedure: Medical Examination
- Other: Questionnaire Administration
- Procedure: Shear Wave Elastography
|
Observational |
|
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Elasticity values
- Strength of associations of tissue elasticity and current conventional methods
|
80 |
All |
22 Years and older (Adult, Senior) |
NCT02676752 |
VICC HN 15135
NCI-2016-00069
P30CA068485 |
|
September 2016 |
December 2018 |
December 2019 |
February 8, 2016 |
April 10, 2018 |
|
- Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
|
| 29 |
NCT02724514 |
Recruiting |
Multi-Parametric Assessment of Breast Lymphedema |
- Breast Cancer
- Breast Lymphedema
|
- Other: non-invasive image & bioimpedance based techniques
|
Observational |
|
- University Health Network, Toronto
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
- Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
|
60 |
Female |
18 Years and older (Adult, Senior) |
NCT02724514 |
UHN REB 14-8503-C |
|
January 2015 |
November 2016 |
December 2018 |
March 31, 2016 |
September 25, 2017 |
|
- Princess Margaret Cancer Centre
Toronto, Ontario, Canada
|
| 30 |
NCT02318615 |
Not yet recruiting |
Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention |
- Lymphedema
- Breast Neoplasm
|
- Procedure: Immediate Axillary Plasty
|
Interventional |
Not Applicable |
- Peking University People's Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of lymphedema and/or severity of lymphedema
- Shoulder Mobility
- Postoperation seroma
- Acute Upper limb thrombosis
|
450 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT02318615 |
AxLD
PKUPHBR001 |
|
December 2015 |
August 2018 |
August 2020 |
December 17, 2014 |
November 20, 2015 |
|
|
| 31 |
NCT02726477 |
Recruiting |
Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema |
|
- Drug: Wuling San
- Drug: placebo
|
Interventional |
Not Applicable |
- Fourth Affiliated Hospital of Guangxi Medical University
- Liuzhou Maternity and Child Healthcare Hospital
- Liuzhou Hospital of Traditional Chinese Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- volume changes % measured by perometry
- adverse events
|
200 |
Female |
20 Years to 40 Years (Adult) |
NCT02726477 |
PJK2016088 |
|
April 2016 |
September 2017 |
May 2018 |
April 1, 2016 |
May 9, 2016 |
|
- Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou, Guangxi, China - Liuzhou Maternity and Child Healthcare Hospital
Liuzhou, Guangxi, China - The Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
|
| 32 |
NCT02494115 |
Recruiting |
Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients |
|
- Procedure: subcutaneous drainage
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Nice
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- evolution of the patient's discomfort due to his oedemas
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02494115 |
14-PP12 |
|
January 2016 |
January 2017 |
January 2018 |
July 10, 2015 |
September 27, 2016 |
|
- CAL
Nice, Alpes-maritimes, France - Centre Hospitalier
Avignon, France - Centre Hospitalier Universitaire de Nice
Nice, France
|
| 33 |
NCT02992782 |
Recruiting |
Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management |
- Breast Neoplasm
- Lymphedema
|
- Behavioral: Standard Care
- Behavioral: Exercise and Compression Garment
- Behavioral: Exercise and Adjustable Compression Wrap
|
Interventional |
Not Applicable |
- University of Alberta
- Cross Cancer Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Arm Lymphedema Volume
- Bioimpedance Analysis
- Upper body strength
- (and 7 more...)
|
24 |
Female |
18 Years and older (Adult, Senior) |
NCT02992782 |
HREBA - CC 16-1026 |
DREAM |
April 15, 2017 |
July 1, 2018 |
September 30, 2018 |
December 14, 2016 |
April 10, 2018 |
|
- University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada
|
| 34 |
NCT02611557 |
Recruiting |
Lymphedema Progression Screening Using MRI |
|
- Procedure: Manual lymphatic drainage therapy
|
Interventional |
Not Applicable |
- Vanderbilt University
- Vanderbilt University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
|
90 |
Female |
18 Years and older (Adult, Senior) |
NCT02611557 |
Donahue_Lymphedema |
INFORM |
February 2015 |
March 2018 |
June 2018 |
November 23, 2015 |
February 17, 2017 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States - Vanderbilt University
Nashville, Tennessee, United States
|
| 35 |
NCT02803736 |
Not yet recruiting |
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema |
- Breast Cancer
- Lymphedema
- Acupuncture
|
|
Interventional |
Not Applicable |
- Fourth Affiliated Hospital of Guangxi Medical University
- Liuzhou Hospital of Traditional Chinese Medicine
- Liuzhou Maternity and Child Healthcare Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Absolute Reduced Limb Volume Ratio
- Incidence of Adverse Event
|
150 |
Female |
20 Years to 45 Years (Adult) |
NCT02803736 |
PJK201690 |
Acupuncture |
December 2016 |
October 2019 |
December 2019 |
June 17, 2016 |
November 23, 2016 |
|
|
| 36 |
NCT02929121 |
Not yet recruiting |
A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in India |
- Lymphedema
- Lymphatic Filariasis
- Filariasis
|
- Drug: Doxycycline
- Drug: Placebo
|
Interventional |
Phase 3 |
- The Task Force for Global Health
- United States Agency for International Development (USAID)
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Lymphadema Grade
- Change in number of acute attacks
|
250 |
All |
14 Years to 65 Years (Child, Adult) |
NCT02929121 |
LeDoxy2015_India |
LeDoxy-India |
August 15, 2017 |
December 15, 2019 |
December 15, 2019 |
October 10, 2016 |
July 21, 2017 |
|
|
| 37 |
NCT02929134 |
Recruiting |
A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka |
- Lymphedema
- Lymphatic Filariasis
- Filariasis
|
- Drug: Doxycycline
- Drug: Placebo
|
Interventional |
Phase 3 |
- The Task Force for Global Health
- United States Agency for International Development (USAID)
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Lymphadema Grade
- Change in number of acute attacks
|
250 |
All |
14 Years to 65 Years (Child, Adult) |
NCT02929134 |
LeDoxy2015_SriLanka |
LeDoxy-SL |
February 16, 2018 |
December 15, 2019 |
December 15, 2019 |
October 10, 2016 |
February 19, 2018 |
|
- University of Ruhuna
Galle, Southern Province, Sri Lanka
|
| 38 |
NCT02927496 |
Not yet recruiting |
A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali |
- Lymphedema
- Lymphatic Filariasis
- Filariasis
|
- Drug: Doxycycline
- Drug: Placebo
|
Interventional |
Phase 3 |
- The Task Force for Global Health
- United States Agency for International Development (USAID)
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Lymphedema
- Change in number of acute attacks
|
250 |
All |
14 Years to 65 Years (Child, Adult) |
NCT02927496 |
LeDoxy2015_Mali |
LeDoxy-Mali |
August 15, 2017 |
December 15, 2019 |
December 15, 2019 |
October 7, 2016 |
July 21, 2017 |
|
|
| 39 |
NCT03210311 |
Recruiting |
Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema |
- Lymphedema of Upper Arm
- Breast Cancer
- Diagnoses Disease
|
|
Interventional |
Phase 3 |
- Universitaire Ziekenhuizen Leuven
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Treatment
|
- Incidence of lymphedema of arm and hand
- Change of lymphatic architecture and function
- Change of change of extracellular fluid
- (and 4 more...)
|
125 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03210311 |
S60382
2017-002306-12 |
DEARLY |
October 9, 2017 |
November 1, 2021 |
January 1, 2022 |
July 6, 2017 |
October 9, 2017 |
|
- Vascular surgey Lymphovenous center
Leuven, vlaams Brabant, Belgium
|
| 40 |
NCT03030859 |
Not yet recruiting |
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis |
- Head and Neck Cancer
- Lymphedema
- Fibrosis
|
- Other: Usual Care
- Other: Usual Care plus LEF-SCP
- Other: Usual Care plus LEF-SCP plus Follow-up
|
Interventional |
Not Applicable |
- Vanderbilt-Ingram Cancer Center
- American Cancer Society, Inc.
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Feasibility of the LEF-SCP evaluated by Recruitment Log
- Self-efficacy assessed by Perceived Medical Condition Self-Management Scale (PMCSMS)
- Self-care adherence evaluated by Self-Care Checklist
- Preliminary efficacy assessed by LEF status
|
98 |
All |
21 Years and older (Adult, Senior) |
NCT03030859 |
VICC HN 16150
NCI-2016-01901 |
|
May 2018 |
August 2021 |
December 2021 |
January 25, 2017 |
March 22, 2018 |
|
- Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
|
| 41 |
NCT02609724 |
Recruiting |
Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL |
- Breast Neoplasm
- Lymphedema
|
- Other: Information
- Other: Skin care
- Other: Compression therapy
- (and 3 more...)
|
Interventional |
Not Applicable |
- Universitaire Ziekenhuizen Leuven
- Agentschap voor Innovatie door Wetenschap en Technologie
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change of lymphoedema volume of arm/ hand
- Change of stagnation of fluid at level of shoulder/ trunk
- Change of extracellular fluid in arm
- (and 8 more...)
|
201 |
All |
18 Years and older (Adult, Senior) |
NCT02609724 |
IWT150178 |
EFforT-BCRL |
January 2016 |
May 2019 |
December 2019 |
November 20, 2015 |
May 5, 2017 |
|
- Antwerp University Hospital
Antwerp, Belgium - Centre Hospitalier Universitaire (CHU) Sint-Pieter, Lymphoedema Clinic
Brussel, Belgium - University Hospitals of Leuven, lymphovenous center
Leuven, Belgium
|
| 42 |
NCT02691624 |
Recruiting |
Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation |
|
|
Observational |
|
- Peking University People's Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number and relationship with the sentinel lymph node of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy
- Number of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection
- Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy
- Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection
|
100 |
Female |
Child, Adult, Senior |
NCT02691624 |
BCRLResearch001 |
|
October 2015 |
May 2016 |
January 2019 |
February 25, 2016 |
February 25, 2016 |
|
- Peking University People's Hospital
Beijing, Beijing, China
|
| 43 |
NCT02412241 |
Recruiting |
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients |
- Oral Cavity Cancer
- Oropharyngeal Cancer
- Lymphedema
- Fibrosis
|
- Other: LEF measures
- Procedure: Technical measure
|
Interventional |
Not Applicable |
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
- Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility
- Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
- (and 3 more...)
|
90 |
All |
21 Years and older (Adult, Senior) |
NCT02412241 |
VICC SUPP 1529
1R01DE024982-01 |
|
June 2015 |
February 2019 |
February 2019 |
April 9, 2015 |
January 25, 2018 |
|
- Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
|
| 44 |
NCT02946021 |
Recruiting |
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-related Lymphedema |
- Head and Neck Neoplasms
- Head and Neck Lymphedema
- Head and Neck Cancer
|
- Device: Head and neck garments for pneumatic compression device.
- Drug: NIRFLI with ICG
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lymph movement measured by ICG lymphography.
- Dermal backflow measured by ICG lymphography.
- Symptom alleviation measured by survey response.
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT02946021 |
HSC-MS-16-0465 |
|
October 2016 |
February 2018 |
May 2018 |
October 26, 2016 |
January 17, 2018 |
|
- UT Health Science Center at Houston
Houston, Texas, United States
|
| 45 |
NCT01544335 |
Recruiting |
Evaluation of BIS for Quantification of Lymphedema |
|
- Other: Bioimpedance Spectroscopy
|
Observational |
|
- Massachusetts General Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation of impedance ratios obtained through bioimpedance spectroscopy (BIS)with perometric relative arm volume change (RVC) and self-reported symptom data
- Compare relationship between lymphedema diagnostic criteria corresponding to BIS, perometry, and self-reported symptoms
|
200 |
Female |
18 Years and older (Adult, Senior) |
NCT01544335 |
11-325 |
|
December 2011 |
June 2018 |
|
March 5, 2012 |
March 21, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 46 |
NCT03073096 |
Recruiting |
LYMPHA: Eliminating the Burden of Lymphedema in Patients Requiring Nodal Dissection |
|
- Procedure: LVA at time of nodal dissection
|
Interventional |
Not Applicable |
- Ottawa Hospital Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Difference in limb volume between surgery-affected and surgery-unaffected limb at baseline, 3, 6, 9, 12 and 24 months
- Limb-lymphedema-specific Quality of life assessment at baseline, 3, 6, 9, 12 and 24 months through the LYMQOL questionnaire
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03073096 |
20170146 form 6131 |
|
June 1, 2017 |
September 1, 2018 |
September 1, 2019 |
March 8, 2017 |
September 21, 2017 |
|
- The Ottawa Hospital
Ottawa, Ontario, Canada
|
| 47 |
NCT02977182 |
Recruiting |
Lymphedema Treatment for Blunt Facial Trauma |
- Post-traumatic Facial Edema
|
- Other: Complete Decongestive Therapy (CDT)
|
Interventional |
Not Applicable |
- Our Lady of the Lake Regional Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02977182 |
9521 |
|
November 2016 |
November 2018 |
November 2018 |
November 30, 2016 |
November 30, 2016 |
|
- Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
|
| 48 |
NCT02384733 |
Recruiting |
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost |
|
- Radiation: Loco-regional RT
|
Interventional |
Not Applicable |
- Danish Breast Cancer Cooperative Group
- Danish Cancer Society
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Development of ipsilateral arm lymphedema
- Fibrosis grade 2-3
- Arm range of motion
- (and 6 more...)
|
2000 |
Female |
18 Years and older (Adult, Senior) |
NCT02384733 |
The Skagen Trial 1 |
|
March 2015 |
March 2036 |
March 2036 |
March 10, 2015 |
August 1, 2017 |
|
- Aarhus University Hospital
Aarhus, Denmark
|
| 49 |
NCT02115477 |
Recruiting |
Lymphedema After Primary Surgery for Endometrial Cancer |
- Carcinoma of the Endometrium
- Hysterectomy
- Lymphadenectomy
|
- Procedure: Lymphadenectomy
|
Observational |
|
- Preben Kjolhede, MD, professor
- Swedish Cancer Society
- Medical Research Council of Southeast Sweden
- (and 3 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively
- Change in leg volume from baseline (preoperatively) to 6 months postoperatively
- Change in leg volume from baseline (preoperatively) to 12 months postoperatively
- (and 5 more...)
|
260 |
Female |
18 Years and older (Adult, Senior) |
NCT02115477 |
Version 2013-09-22/2014-03-21
The Swedish Cancer Society |
LASEC |
April 2014 |
June 2017 |
June 2018 |
April 16, 2014 |
February 23, 2016 |
|
- Highland hospital
Eksjo, Jonkopings län, Sweden - Falu Central Hospital
Falun, Sweden - Gävle County Hospital
Gävle, Sweden - (and 13 more...)
|
| 50 |
NCT03105440 |
Recruiting |
Innovation Oncological Rehabilitation: Applicability of the Different Techniques Physiotherapeutic Post Breast Cancer |
|
- Other: Virtual reality
- Other: Vibration therapy
- Other: Hand cycling
- (and 3 more...)
|
Interventional |
Not Applicable |
- Universidade do Vale do Paraíba
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
6 |
Female |
30 Years to 70 Years (Adult, Senior) |
NCT03105440 |
41887715.0.0000.5503 |
|
January 2013 |
April 2017 |
January 2019 |
April 10, 2017 |
April 19, 2017 |
|
- University of Vale do Paraíba
São José dos Campos, SP, Brazil
|
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