A Phase 2 interventional study of VITAMIN D in Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Phase 2, Interventional, and Supportive care
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 57 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 138 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Normalisation of Vitamin D level
percentage of vitamin D level normalisation
Time frame: from the Cycle 1 to cycle 6 (each cycle is 21 days)
initial vitamin D and calcium level
blood test
Time frame: at cycle 1( one cycle is 21 days)
normalization of 25-OHD (vitamin D)
blood test
Time frame: at FU 6,12,18,24 months after the first dose of vitamin D
adverses events rates
graded based on NCI-CTCAE v4.03
Time frame: from cycle 1 to follow-up 24 months (one cycle is 21 days)
vitamin D and calcium level
blood test
Time frame: from cycle 1 to 24 months (one cycle is 21 days)
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Institut du Cancer de Montpellier - Val d'Aurelle