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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen..
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 months · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- 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, ...).
Primary outcome measures
- Rate of patients who adhere to tamoxifen treatment. [Time frame: 18 months after the start of the research]
Secondary outcome measures (3)
- Rate of patients taking ACT. [Time frame: 18 months after the start of the research]
- Rate of patients consuming turmeric-based dietary supplements. [Time frame: 18 months after the start of the research]
- Plasma concentration of tamoxifen in patients. [Time frame: 18 months after the start of the research]
Eligibility criteria
Inclusion criteria
- 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.
- Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse
Identifiers
NCT: NCT04740697 · 20 SEIN 13