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

Breast Cancer Clinical Trial

— EUTACAM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740697
• Other study ID #: 20 SEIN 13
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Institut Claudius Regaud
• Contact: Florence DALENC
• Phone: 05 31 15 51 04
• Email: dalenc.florence[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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, ...).

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who adhere to tamoxifen treatment.	This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.	18 months after the start of the research
Secondary	Rate of patients taking ACT.		18 months after the start of the research
Secondary	Rate of patients consuming turmeric-based dietary supplements.		18 months after the start of the research
Secondary	Plasma concentration of tamoxifen in patients.		18 months after the start of the research