Night-time Compression Systems for Breast Cancer Related Lymphedema

This study has been completed.
Sponsor:
Collaborators:
AHS Cancer Control Alberta
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01550250
First received: March 7, 2012
Last updated: July 16, 2014
Last verified: July 2012
  Purpose

Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine night-time compression system garments for lymphedema. Our objective is to determine if breast cancer survivors are willing and able to use the garment overnight to help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled in the 24-week long study. Measurements will be taken of each arm to assess the extent of lymphedema and to measure changes over the study period. We will also examine other outcomes such as the impact of the night-time compression system garment on sleep. The study will provide important information on the feasibility of night-time compression system garments as a self-management strategy for lymphedema.


Condition Intervention Phase
Breast Neoplasms
Lymphedema
Behavioral: Night-time compression system garment
Behavioral: Day-time compression sleeve
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Feasibility of Night-time Compression Systems for Breast Cancer Related Lymphedema: a Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Accrual rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The number of women eligible for the study and number agreeing to participate.


Secondary Outcome Measures:
  • Adherence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Data on adherence to wearing the night-time compression system.


Enrollment: 30
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Night-time Compression
Women randomized to the immediate night-time compression system group will be measured for a custom-made night-time compression system. Women in this group will be instructed to wear their night-time compression system garment for a minimum of 5 nights per week over the 12-week intervention period. A gradual increase in nights worn and wear-time of the garment will occur over the first two weeks. From weeks 3 to 12 of the study, the participants will be asked to wear the garment for 8 hours per night, for a minimum of five nights per week.
Behavioral: Night-time compression system garment
Night-time compression system garment 8 hours per night for a minimum of 5 nights per week.
Behavioral: Day-time compression sleeve
Standard care for lymphedema maintenance. Day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week.
Active Comparator: Delayed Group: Standard Care
Women randomized to the delayed night-time compression system group will receive standard care for lymphedema maintenance. Each participant will be instructed to wear their day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week. Following the twelve-week delay period, women in this arm of the trial will be fitted for their respective night-time compression system garment and will follow the protocol outlined in the experimental arm of the trial.
Behavioral: Day-time compression sleeve
Standard care for lymphedema maintenance. Day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
  2. Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
  3. Patients must have their own fitted compression garment for daytime maintenance.
  4. No past or current use of a night-time compression system for maintenance. Those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.

Exclusion Criteria:

  1. Clinical or radiological evidence of active disease, either local or metastatic.
  2. History of contralateral breast cancer and axillary surgery.
  3. Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
  4. Patients for whom compression is contraindicated.
  5. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
  6. Unable to comply with the protocol, measurement and follow-up schedule.
  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: NCT01550250

Locations
Canada, Alberta
Holy Cross Centre
Calgary, Alberta, Canada, T2S 3C1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
University of Alberta
AHS Cancer Control Alberta
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Margaret L. McNeely, PhD University of Alberta and Alberta Health Services
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01550250     History of Changes
Other Study ID Numbers: ACREC-25845
Study First Received: March 7, 2012
Last Updated: July 16, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Breast cancer
Arm lymphedema
Compression therapy

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

ClinicalTrials.gov processed this record on July 22, 2014