EUTACAM: 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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Recruiting

CT.gov ID

NCT04740697

Collaborator

(none)

200

Enrollment

Location

Arm

17.6

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 12, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient with localized breast cancer.	Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. 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, ...).

Arm

Intervention/Treatment

Other: Patient with localized breast cancer.

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

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, ...).

Outcome Measures

Primary Outcome Measures

Rate of patients who adhere to tamoxifen treatment. [18 months after the start of the research]
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.

Secondary Outcome Measures

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]
Plasma concentration of tamoxifen in patients. [18 months after the start of the research]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).