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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Biological: Blood sample

• Registration Number: NCT03249389
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-08
• Study First Submitted: 2016-08-29
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-14
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, France