None listed
Conditions
Brief 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.
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
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.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Women aged 18 years old or older. • Early breast cancer diagnosis (T0is-T3, N0-3, M0), Stage I-III ipsilateral breast cancer treated with BCS • RT delivered following BCS • RT completed 3 months to 3 years ago • completed any adjuvant therapy (excluding hormone treatments) at least 6 months previously; • Bothersome breast oedema (score of equal or greater than 3 on BOB visual analogue scale) • Available for initial breast oedema assessment, treatment (six treatments over 3 weeks)
Exclusion criteria
• Aged <18 years old • Currently receiving lymphoedema treatment for breast lymphoedema • Breast implants – prior or current • Previous RT treatment to either breast, contralateral chest wall or thoracic region • Pregnant • Metastatic disease • Mastectomy +/- reconstruction, • Previous contralateral breast cancer treatment • Bilateral breast cancer • Unable to attend for breast oedema assessment and treatment • have a pacemaker, metal implant, suffer from claustrophobia, are unable to lie on their stomach with arms above their head or any other MRI-incompatible implant; • Skin concerns limiting suitability to receive treatment
Outcome results
None listed