Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05069402
Eligibility Criteria:
Inclusion Criteria:
* no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) \< 18),
* good general status (Karnofsky Performance Index \> 80,
* Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
* no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease \[COPD\], coronary aortic bypass graft \[CABG\], etc.),
* no history of known allergies or drug intolerance to analyzed substances.
Exclusion Criteria:
* Patients malnourished or with metastatic disease,
* pregnant,
* in poor general status (Karnofsky \<80, Eastern Cooperative Oncology Group (ECOG) \> 1),
* recent history of severe heart, lung, kidney or liver failure,
* history of allergies or drug intolerance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05069402
Study Brief:
Protocol Section:
NCT05069402