Clinical trial NCT01550250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lymphedema
Keywords: Breast cancer
Arm lymphedema
Compression therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Canadian Breast Cancer Foundation
First posted: 2012-03-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Accrual rate
timeFrame: 18 months
Secondary outcomes:
measure: Adherence
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Holy Cross Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta and Alberta Health Services
name: Margaret L. McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: