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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)

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ClinicalTrials.gov Identifier: NCT02187289
Recruitment Status : Unknown
Verified December 2017 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Lymphedema Device: Night-time compression bandages Device: Compression Sleeve, daytime wear Device: Night-time Compression custom-made garment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial
Study Start Date : October 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany) [ Time Frame: 12 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187289


Locations
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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Mount St. Joseph Hospital/Holy Family (MSJ/HF)
Vancouver, British Columbia, Canada, V5T 3N4
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
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Principal Investigator: Margaret McNeely, PhD Cross Cancer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02187289    
Other Study ID Numbers: HREBA CC-14-0066
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
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:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases