RecruitingNCT07249775

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

AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

120 participants

Start Date

Oct 8, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new nutritional supplement called FID-022 designed specifically for patients with pancreatic cancer. The goal is to assess whether it is safe and feasible to use alongside standard pancreatic cancer treatment, aiming to support nutritional status and quality of life. **You may be eligible if...** - You are 18 or older - You have confirmed or strongly suspected pancreatic cancer (including various types of pancreatic cancer) - Your cancer may be at any stage — resectable, borderline, locally advanced, or metastatic - You are able to eat by mouth (no feeding tube or IV nutrition) - You can read and speak English - You are able to provide written consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are currently using a feeding tube or receiving nutrition through a vein - You have significant fluid buildup in your abdomen (ascites) - You have a history of bowel obstruction or a condition that limits eating - You have a severe or uncontrolled psychiatric illness - You have other serious uncontrolled health conditions (such as active infection or heart/liver failure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBaseline 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.

OTHERExtended Lifestyle Monitoring

Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.

OTHERFeasibility Survey

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


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07249775


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