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
Recruiting · NCT04740697 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Claudius Regaud
View the official record on ClinicalTrials.gov →Interventions studied
Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
What this trial is about
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.
Who can take part
Age range
18 Months and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- Institut Universitaire du Cancer de Toulouse - Oncopole - Toulouse, France