Breast Cancer
Conditions
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
Interventions
DIETARY_SUPPLEMENTVITAMIN D
ORAL SOLUTION (2 ml) at 100.000 UI
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A phase 2 clinical trial not randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalisation of Vitamin D level | from the Cycle 1 to cycle 6 (each cycle is 21 days) | percentage of vitamin D level normalisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| initial vitamin D and calcium level | at cycle 1( one cycle is 21 days) | blood test |
| normalization of 25-OHD (vitamin D) | at FU 6,12,18,24 months after the first dose of vitamin D | blood test |
| adverses events rates | from cycle 1 to follow-up 24 months (one cycle is 21 days) | graded based on NCI-CTCAE v4.03 |
| vitamin D and calcium level | from cycle 1 to 24 months (one cycle is 21 days) | blood test |
Countries
France
Outcome results
None listed