Clinical trial NCT03249389: Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)
Official title: Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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).

Primary outcomes:
measure: Assess the percentage of occurrence of a hypercalciuria
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Assess of vitamin and calcium balance
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: William JACOT
role: STUDY_CHAIR
References: