Breast Cancer
Conditions
Keywords
Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric
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.
Interventions
OTHERTreatment 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
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Months to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
CONTACTFlorence DALENC
Outcome results
None listed