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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: VITAMIN D

• Registration Number: NCT04091178
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-10
• Primary Completion: 2015-06-11
• Study Completion: 2017-03-16
• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Study First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VITAMIN D SUPPLEMENTATION ARM	VITAMIN D	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.

Primary Outcome Measures

Name	Time	Method
Normalisation of Vitamin D level	from the Cycle 1 to cycle 6 (each cycle is 21 days)	percentage of vitamin D level normalisation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France