RecruitingACTRN12620000342910

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


Sponsor

Westmead Hospital

Enrollment

40 participants

Start Date

Jan 29, 2021

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After breast cancer surgery and radiotherapy, some women develop persistent swelling in the breast known as breast oedema — a build-up of fluid under the skin that causes heaviness, tightness, and discomfort. This randomised trial tests whether a combination of manual lymphatic drainage (a specialised massage technique) and wearing a compression bra can reduce this oedema and improve how the breast feels and looks. Participants are randomly assigned to either receive the treatment immediately (two 1-hour manual drainage sessions per week for 3 weeks, plus wearing a compression bra 12 hours daily) or to a waiting-list group that receives treatment after 3 weeks. All participants have MRI, mammogram, and ultrasound scans and complete symptom questionnaires. You may be eligible if you are a woman aged 18 or over who completed radiotherapy for early breast cancer (after breast-conserving surgery) between 3 months and 3 years ago, and have bothersome breast swelling. You should not currently be receiving lymphoedema treatment, have breast implants, have metastatic disease, or have had a mastectomy. You must be able to attend the treatment sessions and have no contraindications to MRI scanning.

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 l

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.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

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ACTRN12620000342910


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