Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer

Study Overview
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Brief Summary
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An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy. A calcium supplementation will be prescribed in parallel. An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy

Official Title
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A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: VITAMIN D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy Women ≥ 18 years old (no age limit) Performance status :0 or 1 Patients must be affiliated to a Social Security System Signed informed consent obtained before any study specific procedures. Vitamin D deficiency confirmed ( vitamin D result must be < at 30 ng/ml) Exclusion Criteria: Metastatic disease Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level) Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose < 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated Concomittant treatment with an other experimental product Pregnant or breastfeeding women Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A phase 2 clinical trial not randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VITAMIN D SUPPLEMENTATION ARM<br>On day 1 of every chemotherapy cycle, the patient will be receive an oral solution of vitamin D (UVEDOSE/calciferol). In parallel,a calcium supplementation is prescribed. | Dietary Supplement: VITAMIN D<br>* ORAL SOLUTION (2 ml) at 100.000 UI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalisation of Vitamin D level | percentage of vitamin D level normalisation | from the Cycle 1 to cycle 6 (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial vitamin D and calcium level | blood test | at cycle 1( one cycle is 21 days) | 
| normalization of 25-OHD (vitamin D) | blood test | at FU 6,12,18,24 months after the first dose of vitamin D | 
| adverses events rates | graded based on NCI-CTCAE v4.03 | from cycle 1 to follow-up 24 months (one cycle is 21 days) | 
| vitamin D and calcium level | blood test | from cycle 1 to 24 months (one cycle is 21 days) |