Pilot 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 Regaud2 sites in 1 country200 target enrollmentFebruary 12, 2021

ConditionsBreast Cancer

InterventionsTreatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Overview

Phase: N/A
Intervention: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Conditions: Breast Cancer
Sponsor: Institut Claudius Regaud
Enrollment: 200
Locations: 2
Primary Endpoint: Rate of patients who adhere to tamoxifen treatment.
Status: Recruiting
Last Updated: 12 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 12, 2021

End Date

February 1, 2028

Last Updated

12 days ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut Claudius Regaud

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria

•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).

Arms & Interventions

Patient with localized breast cancer.

Intervention: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Outcomes

Primary Outcomes

Rate of patients who adhere to tamoxifen treatment.

Time Frame: 18 months after the start of the research

This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.

Secondary Outcomes

Plasma concentration of tamoxifen in patients.(18 months after the start of the research)
Rate of patients taking ACT.(18 months after the start of the research)
Rate of patients consuming turmeric-based dietary supplements.(18 months after the start of the research)