BaROQUE: RCT - Breast Oedema: Quantify and Improve: Assessment and treatment of breast oedema in women following breast cancer treatment - A randomised controlled trial
BaROQUE: RCT - Breast Oedema: Quantify and Improve: Effect of treatment of breast oedema on self reported symptoms and objective measures in women following breast cancer treatment - A randomised controlled trial
Westmead Hospital
40 participants
Jan 29, 2021
Interventional
Conditions
Summary
The purpose of this study is to see if a program of manual drainage and use of a compression bra can improve outcomes for breast cancer patients experiencing post-treatment oedema (accumulation of fluid under the skin). Who is it for? You may be eligible for this study if you are aged 18 or over, have completed radiotherapy for breast cancer in the last 3 years and are experiencing oedema in the breast. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive the intervention, which involves two 1 hour sessions of manual drainage per week for 3 weeks, and wearing a compression bra for 12 hours a day for this period. The other group will receive be referred to a lymphoedema clinic for treatment and receive the compression bra after a 3 week waiting period. As part of this study, all participants will have a number of scans (including MRI, mammogram and ultrasound) and answer some questionnaires about their symptoms. It is hoped this research will demonstrate the program being tested can improve outcomes for patients with breast cancer treatment-related oedema.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
1 hour long individual face to face treatment sessions will be completed twice per week for 3 weeks (6 sessions in total) at the Westmead Hospital Breast Cancer Institute. Treatment includes Manual lymphatic drainage which is a technique performed by a trained lymphoedema therapist to move fluid from the swollen area (breast/arm area) to an area that has normal lymphatic drainage. It involves the therapist applying very gentle pressure to the skin in slow rhythmic movements. Participants will also receive verbal and written instruction on caring for their skin (using moisturiser) and be provided with 2 compression bras to wear 12 hours daily for 3 weeks (Bellisse bra - Jobst). Women will be asked to complete a daily diary of how long they wore the bra for and any issues with comfort.
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ACTRN12620000342910