Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.
Inclusion Criteria:
- Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12
months prior to study enrollment
- WHO performance status 0-1
- Age ≥18 years old
- Affiliation to a social security regime or beneficiary of equivalent social
protection
- Written informed consent provided before any study specific procedures
Complementary inclusion criterion for randomization
- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75
nmol/L).
Exclusion Criteria:
- Metastatic disease
- History or presence of any other malignancy (except curatively treated nonmelanoma
skin cancer or in situ cervix carcinoma) ………….
traités dans les 5 ans précédents.
- Contraindication to calcium or cholecalciferol
- Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of
the excipients.
- Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
- Calcium lithiasis and tissue calcification
- Hypervitaminosis D
- Presence of significant comorbidities:
i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory
testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium
supplements
- Concomitant treatment with other experimental products or another vitamin D calcium
treatment
- Pregnancy, breastfeeding or of reproductive potential not using an effective
contraceptive method
- Legal inability or restricted legal ability. Medical or psychological conditions not
allowing proper study completion or informed consent signature