Diet, Exercise and Vitamin D in Breast Cancer Recurrence (DEDiCa)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet
Eligibility Criteria
Inclusion Criteria:
- Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis.
- Age ≥ 30 and < 75 years.
- Patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment.
Exclusion Criteria:
- Patients who do not possess the inclusion criteria for this study.
- Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL).
- Patients with any previous or current concomitant other malignant cancer.
- Pregnant or lactating women.
- Patients with AIDS diagnosis
- Patients with severe renal insufficiency
- Patients with kidney stones (nephrocalcinosis or nephrolithiasis)
- Patients participating in other lifestyle clinical trials
Sites / Locations
- Centro Riferimento Oncologico
- Azienda Ospedaliera Cannizzaro
- Clinica Mediterranea
- Istituto Nazionale Tumori Fondazione G. Pascale
- Ospedale dei Colli Monaldi
- Ospedale Evangelico Betania
- Ospedale San Vincenzo
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group A (high intensity program):
Group B (lower intensity program)
Diet: low glycemic index (GI) Mediterranean diet. All carbohydrate foods will be low GI choices (GI<70 on bread scale, e.g. legumes, pasta al dente, barley, oat, apples, oranges, berries, nuts) within a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). Moderate physical activity: brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity. Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach blood levels of 60-80 ng/ml of 25(OH)D.
Diet: general recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). Basic physical activity: general recommendations to avoid sedentary behaviour. Vitamin D supplement (cholecalciferol) will be given only if vitamin D insufficiency is detected to reach blood levels of 30 ng/ml of 25(OH)D.