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

September 13, 2019 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VITAMIN D SUPPLEMENTATION ARM

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
ORAL SOLUTION (2 ml) at 100.000 UI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalisation of Vitamin D level
Time Frame: from the Cycle 1 to cycle 6 (each cycle is 21 days)
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
Time Frame: at cycle 1( one cycle is 21 days)
blood test
at cycle 1( one cycle is 21 days)
normalization of 25-OHD (vitamin D)
Time Frame: at FU 6,12,18,24 months after the first dose of vitamin D
blood test
at FU 6,12,18,24 months after the first dose of vitamin D
adverses events rates
Time Frame: from cycle 1 to follow-up 24 months (one cycle is 21 days)
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
Time Frame: from cycle 1 to 24 months (one cycle is 21 days)
blood test
from cycle 1 to 24 months (one cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: WILLIAM JACOT, MD, Institut Régional Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2013

Primary Completion (ACTUAL)

June 11, 2015

Study Completion (ACTUAL)

March 16, 2017

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (ACTUAL)

September 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM2013/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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