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NCT Number: NCT04740697

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 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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Health Behavior Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 month and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location status: Recruiting

Location contact

Florence DALENC

CONTACT

[email protected]

05 31 15 51 04

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Other

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 outcomes

  1. Rate of patients who adhere to tamoxifen treatment.

    Time frame: 18 months after the start of the research

    This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.

Secondary outcomes

  1. Rate of patients taking ACT.

    Time frame: 18 months after the start of the research

  2. Rate of patients consuming turmeric-based dietary supplements.

    Time frame: 18 months after the start of the research

  3. Plasma concentration of tamoxifen in patients.

    Time frame: 18 months after the start of the research

Study contacts

Contact information is provided by the study sponsor or research team.

Florence DALENC

CONTACT

[email protected]

05 31 15 51 04

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study 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

Acronym: EUTACAM

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2021
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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