Topic: National Cancer Research Network
Conditions
Interventions
Comparison group (n = 85)
Continuous energy restricted Mediterranean diet plus an exercise intervention (2.5 hours/ moderate activity week)
Intervention group (n = 85)
Sponsors
University Hospital of South Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Scheduled to have standard adjuvant or neoadjuvant chemotherapy 2. Breast cancer stage I to III 3. Any age >18 years: weight affects prognosis amongst preand post menopausal women 4. BMI>19 Kg / m2 (Using IER and exercise we aim to avoid weight gain in all patients; this may lead to some weight loss in normal weight individuals). 5. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries. 6. Resident within Greater Manchester or Cheshire area only in order to maximise uptake and retention to interventions and study. 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Metastatic disease 2. Previouly had chemotherapy for breast or any cancer within the last 2 years. 3. Physical/or psychiatric conditions which may impair compliance to the diet or physical activity interventions assessed from medical history by recruitment nurse/ clinician i.e. Serious digestive and/or absorptive problems, including inflammatory bowel disease. Cardiovascular, respiratory (determined from recent preoperative ECG, chest X?ray, and verified from baseline fitness assessment by the trial exercise specialist (DM) Musculoskeletal disease or joint problems. Psychiatric disorders or conditions, e.g. untreated major depression, psychosis, substance abuse, severe personality disorder. 4. Medications affecting weight e.g. metformin or continuous daily steroids (23 days with chemotherapy allowed) 5. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the diabetiologist. Non-insulin requiring diabetics are eligible for the study. 6. Already commenced chemotherapy. 7. Scheduled to have weekly paclitaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight, body fat (DXA, impedence), waist and hips measured twice at baseline and post chemotherapy appointments | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood markers of chemotherapy associated toxicity measured twice at the first and final chemotherapy cycles 2. Examining the effects of the restricted and normal intake phases measured once at the final chemotherapy cycles 2. Quality of life and fatigue (functional assessment of cancer therapy; FACT-B, FACT-ES and FACT-F; measured twice at baseline and post chemotherapy appointments; 3. Serum markers of breast cancer risk prognosis measured twice at baseline and post chemotherapy appointments 4. Serum markers of cardiovascular disease measured twice at baseline and post chemotherapy appointments 5. Fitness measured twice at baseline and post chemotherapy appointments 6. Blood markers of oxidative stress measured twice at baseline and post chemotherapy appointments 7. Motivational, stage of behaviour change, health beliefs, and self-efficacy scales measured twice at baseline and post chemotherapy appointments 8. Dietary intake (7 day food diary), accelerometer and physical activity questionnaire measured at three times at baseline, post chemotherapy appointments, and half way through chemotherapy 9. Differences in self reported chemotherapy toxicity measured at each chemotherapy cycle | — |
Countries
England, United Kingdom
Outcome results
None listed