Status:
COMPLETED
Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast cancer.
Detailed Description
In view of the absence of data published on the changes of the vitamin and calcium metabolism in patients of a breast cancer receiving adjuvant chemotherapy combined with corticosteroids in antiemetic...
Eligibility Criteria
Inclusion
- Mammary adenocarcinoma to receive 6 cycles of adjuvant chemotherapy.
- Performance index according to who less than or equal to 1.
- Patient older than 18 years and older.
- Patient affiliated to a social security scheme or beneficiary of an equivalent French social protection system
- The informed consent signed and before any procedures specific to the test screening.
- Pregnancy test negative for women and a means of contraception for women and men of reproductive age
Exclusion
- The presence of metastatic disease.
- Other cancer (except basal-cell skin carcinoma and cancer of the cervix in situ treated adequately and curative) treated in the 3 previous years.
- Contraindications for the calcium and colecalciferol:-severe hypersensitivity to vitamin D or calcium supplementation or any of the excipients
- Pathology and/or conditions causing a hypercalcemia and/or hypercalciuria
- Calcium lithiasis - tissue calcification
- Hypervitaminosis D • Presence of significant co-morbidities: Uncontrolled endocrine disease. Known disorders of the phospho-calcium balance in the last 3 years. Osteopenia or osteoporosis proven treatment vitamin and calcium.
- Concomitant treatment with experimental products.
- Pregnant or nursing
- Legal incapacity or limited legal capacity. Medical or psychological conditions, allowing the subject to complete the study or to sign the consent (art.) L.1121 - 6, L.1121 - 7, L.1211 - 8, L1211-9).
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03249389
Start Date
October 1 2015
End Date
September 1 2016
Last Update
August 15 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut régional du Cancer de Montpellier
Montpellier, France, 34298