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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

• Registration Number: NCT04740697
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-02-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with localized breast cancer.	Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France