A First-in-Human Study of FID-022 in Solid Tumor Patients

Brief summary public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Other: Baseline Lifestyle and Symptom Assessment. Dietary questionnaire (VioScreen), symptom and QoL surveys (ESAS-r, FAACT, PROMIS PF, PG-SGA), physical activity survey (Modified GLTEQ), functional fitness tests, DEXA scans, blood draws.

Intervention public domain (ClinicalTrials.gov)

Other: Extended Lifestyle Monitoring. Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.

Intervention public domain (ClinicalTrials.gov)

Other: Feasibility Survey. One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

Arm public domain (ClinicalTrials.gov)

Pancreatic Cancer Patients (): Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.

Arm public domain (ClinicalTrials.gov)

Oncology Clinicians (): Medical oncologists, APPs, dietitians involved in pancreatic cancer care.

Primary outcome public domain (ClinicalTrials.gov)

AI Model Performance. Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use. Time frame: Up to 9 months.

Primary outcome public domain (ClinicalTrials.gov)

Survey Completion Rate. Percentage of patients completing all scheduled questionnaires. Time frame: Up to 9 months.

Primary outcome public domain (ClinicalTrials.gov)

Wearable Adherence. Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks. Time frame: Up to 9 months.

Primary outcome public domain (ClinicalTrials.gov)

Quality of Life Change. Mean change in FAACT total score from baseline to 9 months. Time frame: Up to 9 months.

Primary outcome public domain (ClinicalTrials.gov)

Physical Activity Change. Mean increase in weekly moderate-to-vigorous activity minutes. Time frame: Up to 9 months.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * 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 * Treatment plan likely includes systemic therapy for pancreatic cancer * ECOG performance status 0-2 * Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition * Able to read and speak English * Able to provide written informed consent Exclusion Criteria: * 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 * Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation * Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 120 participants (estimated).