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Night-time Compression Systems for Breast Cancer Related Lymphedema

Primary Purpose

Breast Neoplasms, Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Night-time compression system garment
Day-time compression sleeve
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring Breast cancer, Arm lymphedema, Compression therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Holy Cross Centre
  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Night-time Compression

Delayed Group: Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Accrual rate
The number of women eligible for the study and number agreeing to participate.

Secondary Outcome Measures

Adherence
Data on adherence to wearing the night-time compression system.

Full Information

First Posted
March 7, 2012
Last Updated
June 29, 2020
Sponsor
University of Alberta
Collaborators
Alberta Health services, Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01550250
Brief Title
Night-time Compression Systems for Breast Cancer Related Lymphedema
Official Title
Feasibility of Night-time Compression Systems for Breast Cancer Related Lymphedema: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Health services, Canadian Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Lymphedema
Keywords
Breast cancer, Arm lymphedema, Compression therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Night-time Compression
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Group: Standard Care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Night-time compression system garment
Intervention Description
Night-time compression system garment 8 hours per night for a minimum of 5 nights per week.
Intervention Type
Behavioral
Intervention Name(s)
Day-time compression sleeve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accrual rate
Description
The number of women eligible for the study and number agreeing to participate.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Adherence
Description
Data on adherence to wearing the night-time compression system.
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. Patients must have their own fitted compression garment for daytime maintenance. 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: Clinical or radiological evidence of active disease, either local or metastatic. History of contralateral breast cancer and axillary surgery. Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up. Patients for whom compression is contraindicated. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol. Unable to comply with the protocol, measurement and follow-up schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret L. McNeely, PhD
Organizational Affiliation
University of Alberta and Alberta Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Cross Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C1
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

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Night-time Compression Systems for Breast Cancer Related Lymphedema

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