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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Claudius Regaud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

    Other intervention

    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, ...).

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patient with localized breast cancer.Other 1 intervention

Trial outcomes

Primary outcomes

1

Rate of patients who adhere to tamoxifen treatment.

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

Time frame
18 months after the start of the research

Secondary outcomes

1

Rate of patients taking ACT.

Time frame
18 months after the start of the research
2

Rate of patients consuming turmeric-based dietary supplements.

Time frame
18 months after the start of the research
3

Plasma concentration of tamoxifen in patients.

Time frame
18 months after the start of the research

Other outcomes

Sponsors and contacts

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