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Feasibility of Night-time Compression Systems for Breast Cancer Related Lymphedema: a Pilot Study

Phase 1
18 Years
Open (Enrolling)
Breast Neoplasms, Lymphedema

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Trial Information

Feasibility of Night-time Compression Systems for Breast Cancer Related Lymphedema: a Pilot Study

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Accrual rate

Outcome Description:

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

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Margaret L. McNeely, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta and Alberta Health Services


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Lymphedema
  • Breast cancer
  • Arm lymphedema
  • Compression therapy
  • Breast Neoplasms
  • Neoplasms
  • Lymphedema