Lymphoedema, Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Group 1 Control standard written advice
This group will receive comprehensive standard written advice outlining the importance of weight control, a healthy diet, and the importance of cardiovascular
Sponsors
University Hospital of South Manchester NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in excess arm volume in affected arm assessed with a perometer (Pero-Systems 350S) assessed at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in excess arm volume in affected arm assessed with multi frequency bioelectrical impedance (L-DEX U400 bioimpedance spectroscopy device) 2. Uptake to the trial 3. Acceptability and adherence to the supervised and home based weight loss and exercise only interventions, and any adverse effects associated with the programmes 4. Change in weight, body fat and fat free mass (FFM) (DXA) waist and hip circumferences assessed with DXA and multifrequency 8-electrode BIA method (Tanita MC180) 5. Change in arm mobility, function (quick DASH) 6. Change in quality of life including arm morbidity and fatigue sub scales (FACT-B+ 4, FACT ? F) 7. Change in hand grip strength 8. Change in range of movement in affected arm and shoulder, elbow, wrist and cervical spine; flexion, abduction, extension, adduction, medial and lateral rotation 9. Change in dietary intake (7 -day diet diary) 10. Change in levels of physical activity assessed with a 7 day activity diary, Recent Physical Activity Questionnaire (RPAQ) and 7 day accelerometer | — |
Countries
England, United Kingdom
Outcome results
None listed