Skip to main content
OpenTrials
Completed

NCT Number: NCT01550250

Night-time Compression Systems for Breast Cancer Related Lymphedema

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasms Breast Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Cross Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
  • Patients must have their own fitted compression garment for daytime maintenance.
  • 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

  • Clinical or radiological evidence of active disease, either local or metastatic.
  • History of contralateral breast cancer and axillary surgery.
  • Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
  • Patients for whom compression is contraindicated.
  • Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
  • Unable to comply with the protocol, measurement and follow-up schedule.

Treatment and study plan

Night-time compression system garment

Behavioral

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

Day-time compression sleeve

Behavioral

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.

Primary outcomes

  1. Accrual rate

    Time frame: 18 months

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

Secondary outcomes

  1. Adherence

    Time frame: 24 weeks

    Data on adherence to wearing the night-time compression system.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services
  • Canadian Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.