Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298, France
NCT Number: NCT04091178
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
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 2
Montpellier, 34298, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ORAL SOLUTION (2 ml) at 100.000 UI
Time frame: from the Cycle 1 to cycle 6 (each cycle is 21 days)
percentage of vitamin D level normalisation
Time frame: at cycle 1( one cycle is 21 days)
blood test
Time frame: at FU 6,12,18,24 months after the first dose of vitamin D
blood test
Time frame: from cycle 1 to follow-up 24 months (one cycle is 21 days)
graded based on NCI-CTCAE v4.03
Time frame: from cycle 1 to 24 months (one cycle is 21 days)
blood test
Institut du Cancer de Montpellier - Val d'Aurelle
Other
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
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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