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
NCT ID: NCT04740697
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-02-12
2026-02-28
Brief Summary
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200 patients will be included in the study.
Each patient will be followed for one day.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient with localized breast cancer.
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, ...).
Interventions
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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, ...).
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Months
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20 SEIN 13
Identifier Type: -
Identifier Source: org_study_id
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