Clinical trial · Interventional
Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)
Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant
NCT03249389CI-TRIAL-00105377CALCIOBScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood sample
- 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
- interventionNames
- Biological: Blood sample
Primary outcomes (1)
- measure
- Assess the percentage of occurrence of a hypercalciuria
- timeFrame
- through study completion, an average of 1 year
- 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
Secondary outcomes (1)
- measure
- Assess of vitamin and calcium balance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).References
Publications (1)
- RESULTViala M, Firmin N, Touraine C, Pouderoux S, Metge M, Rifai L, Romieu G, de Forges H, Roca L, Guiu S, D'Hondt V, Jacot W. Changes in vitamin D and calcium metabolism markers in patients undergoing adjuvant chemotherapy for breast cancer. BMC Cancer. 2021 Jul 15;21(1):815. doi: 10.1186/s12885-021-08563-4. PMID 34266398