Back to resultsStudy 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 (EUTACAM)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric
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).
Sites / Locations
- Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with localized breast cancer.
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients who adhere to tamoxifen treatment.
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
Secondary Outcome Measures
Rate of patients taking ACT.
Rate of patients consuming turmeric-based dietary supplements.
Plasma concentration of tamoxifen in patients.
Full Information
NCT ID
NCT04740697
First Posted
February 2, 2021
Last Updated
September 20, 2023
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT04740697
Brief Title
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
Acronym
EUTACAM
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with localized breast cancer.
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Intervention Description
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 Measure Information:
Title
Rate of patients who adhere to tamoxifen treatment.
Description
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
Time Frame
18 months after the start of the research
Secondary Outcome Measure Information:
Title
Rate of patients taking ACT.
Time Frame
18 months after the start of the research
Title
Rate of patients consuming turmeric-based dietary supplements.
Time Frame
18 months after the start of the research
Title
Plasma concentration of tamoxifen in patients.
Time Frame
18 months after the start of the research
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence DALENC
Phone
05 31 15 51 04
Email
dalenc.florence@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence DALENC
Phone
05 31 15 51 04
Email
dalenc.florence@iuct-oncopole.fr
12. IPD Sharing Statement
Learn more about this trial
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
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