Status:
COMPLETED
Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04091178
Start Date
October 10 2013
End Date
March 16 2017
Last Update
September 16 2019
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298