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

Not Applicable

Completed

• Conditions: ymphoedema, Breast Cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN86789850
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-11-30
• Study Start: 2012-10-10
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified