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

Breast Cancer Clinical Trial

— CALCIOBS  

Official title:

Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249389
• Other study ID #: ICM-URC-2014/55
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: August 14, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Secondary	Assess of vitamin and calcium balance	evolution of the different biological markers of vitamin and calcium balance	through study completion, an average of 1 year