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Trials / Completed

CompletedNCT01550250

Night-time Compression Systems for Breast Cancer Related Lymphedema

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALNight-time compression system garmentNight-time compression system garment 8 hours per night for a minimum of 5 nights per week.
BEHAVIORALDay-time compression sleeveStandard 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.

Timeline

Start date
2012-04-01
Primary completion
2013-08-01
Completion
2013-12-01
First posted
2012-03-09
Last updated
2020-07-01

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT01550250. Inclusion in this directory is not an endorsement.

Night-time Compression Systems for Breast Cancer Related Lymphedema (NCT01550250) · Clinical Trials Directory