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Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06435546
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Institut de Cancérologie de Lorraine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Vincent Massard, MDNaoual Boujedaini, PhD
Principal Investigator Affiliation Institut de Cancérologie de LorraineInstitut de Cancérologie de Lorraine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Breast Cancer, Prostate Cancer
Arms & Interventions

Arms

Experimental: Adherence oral anticancer therapies questionnaire

Blood samples

Interventions

Diagnostic Test: - Blood samples

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

Other: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy, France

Status

Recruiting

Address

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, ,

Site Contact

VINCENT MASSARD

[email protected]

+33 3 83 59 40 46

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