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