Night-time Compression Systems for Breast Cancer Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Neoplasms; Lymphedema

• 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

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