Breast Cancer
Conditions
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 aiming and a basal calcium vitamin deficiency. A non randomized study evaluating the percentage of change in the vitamin and calcium balance and the occurrence of a hypercalciuria between initiation and the end of the adjuvant chemotherapy seems necessary, both from the scientific point of view, but also to estimate the usefulness of these markers in clinical practice track. 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
Interventions
BIOLOGICALBlood sample
patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the percentage of occurrence of a hypercalciuria | through study completion, an average of 1 year | Assess the percentage of occurrence of a hypercalciuria between the J1 of the cure 1 and day 1 of the 6 of the adjuvant chemotherapy treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess of vitamin and calcium balance | through study completion, an average of 1 year | evolution of the different biological markers of vitamin and calcium balance |
Countries
France
Contacts
STUDY_CHAIRWilliam JACOT
Institut régional du Cancer de Montpellier
Outcome results
None listed