Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Institut Claudius Regaud200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

Breast Cancer

Interventions

Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.OTHER

Each 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, ...).

Eligibility

Sex: FEMALEMin age: 18 Months

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years at entry into the study. 2. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen. 3. Patients treated with tamoxifen for a maximum of 1 to 3 years. 4. Patient affiliated with a Social Security system in France. 5. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. 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. 3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

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.

Time frame: 18 months after the start of the research

Secondary Outcomes

Rate of patients taking ACT.

Time frame: 18 months after the start of the research

Rate of patients consuming turmeric-based dietary supplements.

Time frame: 18 months after the start of the research

Plasma concentration of tamoxifen in patients.

Time frame: 18 months after the start of the research

Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts