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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
57
ORAL SOLUTION (2 ml) at 100.000 UI
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.