Clinical trial NCT04091178: Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A phase 2 clinical trial not randomized
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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.

Primary outcomes:
measure: Normalisation of Vitamin D level
timeFrame: from the Cycle 1 to cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: initial vitamin D and calcium level
timeFrame: at cycle 1( one cycle is 21 days)
measure: normalization of 25-OHD (vitamin D)
timeFrame: at FU 6,12,18,24 months after the first dose of vitamin D
measure: adverses events rates
timeFrame: from cycle 1 to follow-up 24 months (one cycle is 21 days)
measure: vitamin D and calcium level
timeFrame: from cycle 1 to 24 months (one cycle is 21 days)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: WILLIAM JACOT, MD
role: STUDY_CHAIR
References:
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citation: Abbas S, Nieters A, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Vitamin D receptor gene polymorphisms and haplotypes and postmenopausal breast cancer risk. Breast Cancer Res. 2008;10(2):R31. doi: 10.1186/bcr1994. Epub 2008 Apr 17.
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citation: Mann GB, Kang YC, Brand C, Ebeling PR, Miller JA. Secondary causes of low bone mass in patients with breast cancer: a need for greater vigilance. J Clin Oncol. 2009 Aug 1;27(22):3605-10. doi: 10.1200/JCO.2008.20.2549. Epub 2009 Jun 22.
citation: Chartron E, Firmin N, Touraine C, Chapelle A, Legouffe E, Rifai L, Pouderoux S, Roca L, D'Hondt V, Jacot W. A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy. Nutrients. 2021 Dec 10;13(12):4429. doi: 10.3390/nu13124429.