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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Institut régional du Cancer de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood sample

Arm 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

Outcomes

Primary Outcome Measures

Assess the percentage of occurrence of a hypercalciuria
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

Assess of vitamin and calcium balance
evolution of the different biological markers of vitamin and calcium balance

Full Information

First Posted
August 29, 2016
Last Updated
August 14, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT03249389
Brief Title
Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)
Acronym
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood sample
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention 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
Primary Outcome Measure Information:
Title
Assess the percentage of occurrence of a hypercalciuria
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Assess of vitamin and calcium balance
Description
evolution of the different biological markers of vitamin and calcium balance
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William JACOT
Organizational Affiliation
Institut régional du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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