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Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects

NCT02187289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-21

No results posted yet for this study

Summary

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.

Conditions

Interventions

DEVICE

Night-time compression bandages

Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.

DEVICE

Compression Sleeve, daytime wear

DEVICE

Night-time Compression custom-made garment

Standard Care plus night-time compression by a custom-made night time compression system garment.

Sponsors & Collaborators

  • Cross Cancer Institute

    collaborator OTHER

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Margaret McNeely, PhD · Cross Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-08-31
Completion
2019-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02187289 on ClinicalTrials.gov