Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Breast Cancer

Treatments: Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03249389

ICM-URC-2014/55

Details and patient eligibility

About

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.

Full 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

Enrollment: 146 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

Blood sample

Experimental group

Description:

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

Treatment:

Biological: Blood sample