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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091178
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: VITAMIN D Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A phase 2 clinical trial not randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 10, 2013
Actual Primary Completion Date : June 11, 2015
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. initial vitamin D and calcium level [ Time Frame: at cycle 1( one cycle is 21 days) ]
    blood test

  2. normalization of 25-OHD (vitamin D) [ Time Frame: at FU 6,12,18,24 months after the first dose of vitamin D ]
    blood test

  3. 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

  4. vitamin D and calcium level [ Time Frame: from cycle 1 to 24 months (one cycle is 21 days) ]
    blood test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091178


Locations
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France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: WILLIAM JACOT, MD Institut régional du cancer de Montpellier

Publications of Results:

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04091178     History of Changes
Other Study ID Numbers: ICM2013/06
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Vitamin D Deficiency
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents