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

March 7, 2012
July 16, 2014
April 2012
August 2013   (final data collection date for primary outcome measure)
Accrual rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
The number of women eligible for the study and number agreeing to participate.
Same as current
Complete list of historical versions of study NCT01550250 on ClinicalTrials.gov Archive Site
Adherence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Data on adherence to wearing the night-time compression system.
Adherence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Data on adherence to wearing the night-time compression system: number of days worn per week and number of hours per night.
Not Provided
Not Provided
 
Night-time Compression Systems for Breast Cancer Related Lymphedema
Feasibility of Night-time Compression Systems for Breast Cancer Related Lymphedema: a Pilot Study

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Breast Neoplasms
  • Lymphedema
  • 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.
  • 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.
    Interventions:
    • Behavioral: Night-time compression system garment
    • Behavioral: Day-time compression sleeve
  • 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.
    Intervention: Behavioral: Day-time compression sleeve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2013
August 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01550250
ACREC-25845
Yes
University of Alberta
University of Alberta
  • AHS Cancer Control Alberta
  • Canadian Breast Cancer Foundation
Principal Investigator: Margaret L. McNeely, PhD University of Alberta and Alberta Health Services
University of Alberta
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP