A Study to See Whether Adding Night-time Compression to the Standard Care Will Result in Improved Control of Arm Swelling (Lymphedema) in Breast Cancer Subjects (LYNC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by AHS Cancer Control Alberta
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT02187289
First received: July 9, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.


Condition Intervention
Breast Cancer
Lymphedema
Device: Night-time compression bandages
Device: Compression Sleeve, daytime wear
Device: Night-time Compression custom-made garment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)
Device: Compression Sleeve, daytime wear
Experimental: Standard Care plus Night-time Compression Bandages
Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.
Device: Night-time compression bandages
Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.
Device: Compression Sleeve, daytime wear
Experimental: Standard Care Plus Night-time Compression System Garment
Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment
Device: Compression Sleeve, daytime wear Device: Night-time Compression custom-made garment
Standard Care plus night-time compression by a custom-made night time compression system garment.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
  • Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
  • In or entering upon the maintenance phase of lymphedema treatment.
  • Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
  • No current use of night-time compression (one month wash-out period before trial entry)

Exclusion Criteria:

  • Clinical or radiological evidence of active disease, either local or metastatic
  • History or clinical diagnosis of bilateral arm lymphedema
  • Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
  • Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
  • Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
  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: NCT02187289

Contacts
Contact: Margaret McNeely, PT, MSc, PT, PhD 780-248-1531 mmcneely@ualberta.ca
Contact: Karen Tracey, CCRP 780-432-8699 karen.tracey@albertahealthservices.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Marc Webster, MD    403-521-3093    marc.webster@albertahealthservices.ca   
Principal Investigator: Marc Webster, MD         
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Margaret McNeely, PhD    780-248-1531    mmcneely@ualberta.ca   
Contact: Karen Tracey, CCRP    780-432-8699    Karen.tracey@albertahealthservices.ca   
Sub-Investigator: John Mackey, MD         
Canada, British Columbia
Mount St. Joseph Hospital/Holy Family (MSJ/HF) Not yet recruiting
Vancouver, British Columbia, Canada, V5T 3N4
Contact: Kristin Campbell, BSc.PT, PhD         
Principal Investigator: Kristin Campbell, BSc.PT, PhD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: Margaret McNeely, PhD Cross Cancer Institute
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02187289     History of Changes
Other Study ID Numbers: HREBA CC-14-0066
Study First Received: July 9, 2014
Last Updated: July 23, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
NCSG
Compression bandages
devices
Night time compression
Breast cancer treatment side effects
Compression therapy
Reid Sleeve
Comprefit
Medassist
Tribute
Comprilan

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

ClinicalTrials.gov processed this record on September 22, 2014