Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema (LYMPHATIC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Malaga
Sponsor:
Information provided by (Responsible Party):
Rocío Martín Valero, University of Malaga
ClinicalTrials.gov Identifier:
NCT02165696
First received: June 13, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.


Condition Intervention
Arm Lymphedema After Breast Cancer
Other: Multimodal treatment: compression bandaging and manual lymph drainage.
Other: Manual lymph drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.

Resource links provided by NLM:


Further study details as provided by University of Malaga:

Primary Outcome Measures:
  • Perimetry [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Arm volume is measured with perimetry through truncation of cones formula


Secondary Outcome Measures:
  • Handgrip strength [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"

  • Multiple sit-to-stant test [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Multiple sit-to-stant test will be used to evaluate lower limbs strength.

  • Degree of pain [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™"

  • Pulmonary function test [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Simple spirometry to measure lung function with a spirometer "DATOSPIR120"

  • Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)

  • Six-minute walking test [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Cardiorespiratory functional capacity as measured with six-minute walking test.

  • FACT-B+4 questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92

  • EORTIC-QLQ-C30 questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89

  • QLQ BR23 questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94

  • HADS questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76

  • QuickPIPPER questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961

  • The short version of the IPAQ [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75

  • Qualitative measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Data collection was carried out through an interview in-depth semi-structured. The dimensions of the study were developed based on bibliography and objectives of the study: perceptions and experiences with multimodal treatment, ways of living with lymphedema, life style, Physical activity and exercise.

  • Smartphone-based application [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks ] [ Designated as safety issue: No ]
    Smartphone-based application to analyze the treatment adherence of the participants


Estimated Enrollment: 44
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual lymphatic drainage and compression bandaging
Experimental group: 30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week
Other: Multimodal treatment: compression bandaging and manual lymph drainage.
30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week
Other Name: Multimodal treatment
Active Comparator: Manual lymphatic drainage
Control group: 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
Other: Manual lymph drainage
30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Detailed Description:

This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery.
  • Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer.

Exclusion Criteria:

  • To have received lymphedema treatment previously.
  • To be treated by radiation therapy or chemotherapy.
  • Distant metastases or local recurrence of cancer.
  • Infectious signs in the upper limb with lymphedema.
  • Uncontrolled hypertension.
  • Heart disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165696

Contacts
Contact: Martín-Valero R., Ph D 34 657834413 rovalemas@gmail.com

Locations
Spain
University of Málaga
Málaga, Spain
Sponsors and Collaborators
University of Malaga
  More Information

No publications provided

Responsible Party: Rocío Martín Valero, Ph D, University of Malaga
ClinicalTrials.gov Identifier: NCT02165696     History of Changes
Other Study ID Numbers: UMA_CBM_2014/LYMP, Lymphatic Multimodal Treatment
Study First Received: June 13, 2014
Last Updated: June 13, 2014
Health Authority: Spain: Ethics Commitee

Keywords provided by University of Malaga:
compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014