Night-time Compression Systems for Breast Cancer Related Lymphedema

NCT ID: NCT01550250

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Immediate Night-time Compression

Women randomized to the immediate night-time compression system group will be measured for a custom-made night-time compression system. Women in this group will be instructed to wear their night-time compression system garment for a minimum of 5 nights per week over the 12-week intervention period. A gradual increase in nights worn and wear-time of the garment will occur over the first two weeks. From weeks 3 to 12 of the study, the participants will be asked to wear the garment for 8 hours per night, for a minimum of five nights per week.

Group Type: EXPERIMENTAL

Night-time compression system garment

Intervention Type: BEHAVIORAL

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

Day-time compression sleeve

Intervention Type: 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.

Delayed Group: Standard Care

Women randomized to the delayed night-time compression system group will receive standard care for lymphedema maintenance. Each participant will be instructed to wear their 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. Following the twelve-week delay period, women in this arm of the trial will be fitted for their respective night-time compression system garment and will follow the protocol outlined in the experimental arm of the trial.

Group Type: ACTIVE_COMPARATOR

Day-time compression sleeve

Intervention Type: 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.

Interventions

Night-time compression system garment

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health services

OTHER

Sponsor Role: collaborator

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret L. McNeely, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta and Alberta Health Services

Locations

Holy Cross Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

ACREC-25845

Identifier Type: -

Identifier Source: org_study_id