Overview

Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Treatments:
Calcium
Calcium, Dietary
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
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