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Completed

NCT Number: NCT03249389

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood sample

Biological

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 outcomes

  1. Assess the percentage of occurrence of a hypercalciuria

    Time frame: 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 outcomes

  1. Assess of vitamin and calcium balance

    Time frame: through study completion, an average of 1 year

    evolution of the different biological markers of vitamin and calcium balance

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: CALCIOBS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2017
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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