Evaluating the impact of alternative therapies on tamoxifen adherence in breast cancer patients
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
This study is testing whether using alternative therapies helps breast cancer patients stick to their tamoxifen treatment better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Months and up |
| Sex | Female |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04740697 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess how the use of alternative and complementary therapies affects adherence to tamoxifen treatment in patients with localized hormone-dependent breast cancer. It will involve 200 patients who have been on tamoxifen for 1 to 3 years and will be monitored for one day to gather real-life data on their treatment adherence. The study is conducted at a single center in France, focusing on the relationship between complementary therapies and medication compliance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are being treated for hormone-dependent localized breast cancer with tamoxifen.
Not a fit: Patients who are pregnant, breastfeeding, or have conditions that hinder medical follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment adherence among breast cancer patients, potentially improving their outcomes.
How similar studies have performed: While the specific approach of combining alternative therapies with tamoxifen adherence is novel, similar studies have shown that complementary therapies can positively influence treatment adherence in cancer care.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Toulouse
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Florence DALENC
- Email: dalenc.florence@iuct-oncopole.fr
- Phone: 05 31 15 51 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.