BaROQUE: RCT - Breast Oedema: Quantify and Improve: Assessment and treatment of breast oedema in women following breast cancer treatment - A randomised controlled trial

Not Applicable

Recruiting

• Conditions: Breast Cancer; Lymphoedema - Breast; Cancer - Breast; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Physical Medicine / Rehabilitation - Occupational therapy; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12620000342910
• Lead Sponsor: Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-11
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified