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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 currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by AHS Cancer Control Alberta
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta Identifier:
First received: July 9, 2014
Last updated: December 29, 2015
Last verified: December 2015
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
Device: Night-time compression bandages
Device: Compression Sleeve, daytime wear
Device: Night-time Compression custom-made garment

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm [ Time Frame: 12 weeks ]

Estimated Enrollment: 120
Study Start Date: October 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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT02187289

Contact: Margaret McNeely, PT, MSc, PT, PhD 780-248-1531
Contact: Karen Tracey, CCRP 780-432-8699

Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Contact: Marc Webster, MD    403-521-3093   
Principal Investigator: Marc Webster, MD         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Margaret McNeely, PhD    780-248-1531   
Contact: Karen Tracey, CCRP    780-432-8699   
Sub-Investigator: John Mackey, MD         
Canada, British Columbia
Mount St. Joseph Hospital/Holy Family (MSJ/HF) 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
Principal Investigator: Margaret McNeely, PhD Cross Cancer Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AHS Cancer Control Alberta Identifier: NCT02187289     History of Changes
Other Study ID Numbers: HREBA CC-14-0066 
Study First Received: July 9, 2014
Last Updated: December 29, 2015

Keywords provided by AHS Cancer Control Alberta:
Compression bandages
Night time compression
Breast cancer treatment side effects
Compression therapy
Reid Sleeve

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases processed this record on February 20, 2017