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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

NCT04740697 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

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, ...).

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740697 on ClinicalTrials.gov