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Trial Title:
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers
NCT ID:
NCT06435546
Condition:
Breast Cancer
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood samples
Description:
Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin
Arm group label:
Adherence oral anticancer therapies questionnaire
Intervention type:
Other
Intervention name:
Adherence to anti-cancer therapies questionnaires
Description:
GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and
complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS
Arm group label:
Adherence oral anticancer therapies questionnaire
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancerologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
VINCENT MASSARD
Phone:
+33 3 83 59 40 46
Email:
v.massard@nancy.unicancer.fr
Start date:
June 4, 2024
Completion date:
June 4, 2025
Lead sponsor:
Agency:
Institut de Cancérologie de Lorraine
Agency class:
Other
Source:
Institut de Cancérologie de Lorraine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435546
