A First-in-Human Study of FID-022 in Solid Tumor Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period.
Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease
May or may not have had surgery
Disqualifiers
Pregnant or breastfeeding at the time of enrollment
Current use of tube feeding (enteral) or total parenteral nutrition
Presence of ascites or other findings suggestive of decompensated disease
Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake
Trial design
Treatments tested in this trial
- Baseline Lifestyle and Symptom Assessment
- Extended Lifestyle Monitoring
- Feasibility Survey
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Florida Cancer Innovation Fund
Collaborator
Source ClinicalTrials.gov