Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01480869
Eligibility Criteria:
Inclusion Criteria:
* Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
* WHO performance status 0-1
* Age ≥18 years old
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Written informed consent provided before any study specific procedures
Complementary inclusion criterion for randomization
\- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).
Exclusion Criteria:
* Metastatic disease
* History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….
traités dans les 5 ans précédents.
* Contraindication to calcium or cholecalciferol
* Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients.
* Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
* Calcium lithiasis and tissue calcification
* Hypervitaminosis D
* Presence of significant comorbidities:
i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements
* Concomitant treatment with other experimental products or another vitamin D calcium treatment
* Pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method
* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01480869
Study Brief:
Protocol Section:
NCT01480869