Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS) (CALCIOBS)
Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34298
- Institut régional du Cancer de Montpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the percentage of occurrence of a hypercalciuria
Time Frame: through study completion, an average of 1 year
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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
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess of vitamin and calcium balance
Time Frame: through study completion, an average of 1 year
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evolution of the different biological markers of vitamin and calcium balance
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through study completion, an average of 1 year
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Collaborators and Investigators
Investigators
- Study Chair: William JACOT, Institut régional du Cancer de Montpellier
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICM-URC-2014/55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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