About this trial
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.
200 patients will be included in the study.
Each patient will be followed for one day.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at entry into the study.
Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Patients treated with tamoxifen for a maximum of 1 to 3 years.
Patient affiliated with a Social Security system in France.
Disqualifiers
Pregnant or breastfeeding women.
Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial design
Single group
Treatments tested in this trial
Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Other interventionEach included patient will be referred to the health care staff for a blood sample: * for the determination of the residual plasma concentration of tamoxifen and its active metabolites, * for the constitution of a biobank. Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...).
Treatment groups
Trial outcomes
Primary outcomes
Rate of patients who adhere to tamoxifen treatment.
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
Secondary outcomes
Rate of patients taking ACT.
Rate of patients consuming turmeric-based dietary supplements.
Plasma concentration of tamoxifen in patients.
Sponsors and contacts
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