BE?WEL (Breast - Evaluation of Weight and Exercise for Lymphoedema): A randomised controlled feasibility study to compare four different weight control and exercise programmes for women with breast cancer related lymphoedema

niversity Hospital of South Manchester NHS Foundation Trust (UK)0 个研究点目标入组 60 人开始时间: 2012年10月10日最近更新: 2024年6月3日

适应症

试验速览

2024 Results article in https://doi.org/10.1007/s10549-024-07356-0 (added 20/05/2024)

•1. Women receiving maintenance therapy for breast cancer related arm lymphoedema i.e. compression sleeves + / - manual lymphatic drainage
•2. Overweight/obese BMI > 25 Kg /m2
•3. Stable lymphoedema over the past 3 months defined as:
•3.1. No intensive therapy (i.e. no manual decongestive treatment)
•3.2. No recorded 10% change in volume of the affected arm lasting > 7 days (assessed with perometer)
•3.3. No lymphoedema related infections (cellulitis) requiring antibiotics
•4. Had lymphoedema sleeve reassessed by lymphoedema practitioner within the last 3 months
•5. Any age
•6. Able to understand written instructions and record diet diaries
•7. No chemotherapy in previous 3 months or radiotherapy in the previous 12 months
•8. Live within Greater Manchester / Cheshire area to maximise uptake and retention to programme and study
•9. Sedentary < 40 minute moderate exercise / week
•10. Willing to be randomised to the 4 treatment groups
•11. Written informed consent

•1. Metastatic disease or axillary recurrence
•2. Physical/psychiatric condition which limits compliance to diet and exercise interventions
•3. Eastern Cooperative Oncology Group (ECOG) performance status < 2
•4. Already losing weight or following exercise programme
•5. Plans for surgery during the study period
•6. Pace maker

发起方

niversity Hospital of South Manchester NHS Foundation Trust (UK)