Night-time Compression Systems for Breast Cancer Related Lymphedema

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550250
• Other study ID #: ACREC-25845
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Canada	Holy Cross Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health Services, Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	The number of women eligible for the study and number agreeing to participate.	18 months
Secondary	Adherence	Data on adherence to wearing the night-time compression system.	24 weeks