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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT04803305
Eligibility Criteria:
Key Inclusion Criteria:
* Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
* Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
* Meets any of the following criteria at Randomization:
* Not currently receiving antineoplastic therapy
* On standard of care systemic antineoplastic therapy or treatment without curative intent
* Signed informed consent.
Key Exclusion Criteria:
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
* Current active reversible causes of decreased food intake.
* Current, severe gastrointestinal disease
* Participants with known symptomatic brain metastases requiring steroids.
* Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
* inadequate renal or liver function.
* Women who are pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04803305
Study Brief:
Protocol Section:
NCT04803305