Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer (OPTIVIT)

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Dietary Supplement: VITAMIN D

Study type: Interventional

Funder types: Other

Identifiers

NCT04091178

ICM2013/06

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

VITAMIN D SUPPLEMENTATION ARM

Experimental group

Description:

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.

Treatment:

Dietary Supplement: VITAMIN D