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Night-time Compression Systems for Breast Cancer Related Lymphedema

NCT01550250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-01

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Lymphedema

Interventions

BEHAVIORAL

Night-time compression system garment

Night-time compression system garment 8 hours per night for a minimum of 5 nights per week.

BEHAVIORAL

Day-time compression sleeve

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.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • Canadian Breast Cancer Foundation

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Margaret L. McNeely, PhD · University of Alberta and Alberta Health Services

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550250 on ClinicalTrials.gov