Night-time Compression Systems for Breast Cancer Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Neoplasms; Lymphedema
• Interventions: Behavioral: Night-time compression system garment; Behavioral: Day-time compression sleeve

• Registration Number: NCT01550250
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Study Start: 2012-04
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Night-time Compression	Night-time compression system garment	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.
Delayed Group: Standard Care	Day-time compression sleeve	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.
Immediate Night-time Compression	Day-time compression sleeve	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.

Primary Outcome Measures

Name	Time	Method
Accrual rate	18 months	The number of women eligible for the study and number agreeing to participate.

Secondary Outcome Measures

Name	Time	Method
Adherence	24 weeks	Data on adherence to wearing the night-time compression system.

Trial Locations

Locations (2)

Holy Cross Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada