Night-time Compression Systems for Breast Cancer Related Lymphedema

NCT01550250 | Completed DMC

• 1 other identifier: ACREC-25845
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

Breast cancer; Arm lymphedema; Compression therapy

Outcome Measures

Primary Outcomes (1)

• Accrual rate

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

  18 months

Secondary Outcomes (1)

• Adherence

  24 weeks

Study Arms (2)

Immediate Night-time Compression

EXPERIMENTAL

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.

Behavioral: Night-time compression system garment; Behavioral: Day-time compression sleeve

Delayed Group: Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Day-time compression sleeve

Interventions

Night-time compression system garment BEHAVIORAL

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

Immediate Night-time Compression

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.

Delayed Group: Standard Care; Immediate Night-time Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Canadian Breast Cancer Foundation: collaborator

Study Sites (2)

Holy Cross Centre

Calgary, Alberta, T2S 3C1, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• Margaret L. McNeely, PhD

  University of Alberta and Alberta Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

CA (2)