NCT03249389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

August 29, 2016

Last Update Submit

March 10, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assess of vitamin and calcium balance

    through study completion, an average of 1 year

Study Arms (1)

Blood sample

EXPERIMENTAL

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

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

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

Blood sample

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (1)

  • Viala 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: 34266398RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • William JACOT

    Institut régional du Cancer de Montpellier

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

August 15, 2017

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)