Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

NCT ID: NCT06435546

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2027-06-04

Brief Summary

AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.

Conditions

Breast Cancer; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Adherence oral anticancer therapies questionnaire

Blood samples

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: DIAGNOSTIC_TEST

Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

Adherence to anti-cancer therapies questionnaires

Intervention Type: OTHER

GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS

Interventions

Blood samples

Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

Intervention Type: DIAGNOSTIC_TEST

Adherence to anti-cancer therapies questionnaires

GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult over 18 years old.
• Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
• Oral anticancer medications started for at least 3 months.
• With a performance status ≤ 3.
• Patient has understood, signed and dated the consent form.
• Patient covered by the social security system.

Exclusion Criteria

• Patient with early breast cancer or localized prostate cancer.
• Patient with life expectancy < 3 months.
• Patient in progression
• Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
• Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
• Patient unable to read or speak French.
• Patient already included in another therapeutic trial with an experimental molecule.
• Persons deprived of their liberty or under guardianship (including curatorship).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Massard, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Naoual Boujedaini, PhD

Role: STUDY_CHAIR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Vincent Massard, MD

Role: CONTACT

v.massard@nancy.unicancer.fr

+33383598461

Jean-Louis Merlin, Pr

Role: CONTACT

jl.merlin@nancy.unicancer.fr

+33383656062

Facility Contacts

VINCENT MASSARD

Role: primary

v.massard@nancy.unicancer.fr

+33 3 83 59 40 46

Other Identifiers

2024-A00396-41

Identifier Type: -

Identifier Source: org_study_id