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Completed

NCT Number: NCT04091178

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

ORAL SOLUTION (2 ml) at 100.000 UI

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study 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

Acronym: OPTIVIT

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Sep 16, 2019
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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