Actively Recruiting
AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-01-28
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
F
Florida Cancer Innovation Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multimodal artificial intelligence (AI) model for the early detection of cancer-associated cachexia in patients with pancreatic cancer. This observational study also aims to assess how feasible and acceptable diet and exercise interventions are for managing cachexia. The study will analyze both retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center. Participants include patients with newly diagnosed pancreatic adenocarcinoma at various stages, along with oncology clinicians involved in their care. The study involves baseline lifestyle and symptom assessments using dietary questionnaires, quality of life and symptom surveys, physical activity surveys, functional fitness tests, DEXA scans, and blood draws. Extended monitoring includes wearable devices such as Fitbit, diet and activity preference surveys at 9 months, and a one-time survey to assess the integration of diet and exercise into clinical practice. During the study, participants will complete surveys and wear activity monitors for up to 9 months to track quality of life, physical activity changes, and adherence to wearable devices. Researchers will evaluate the AI model's performance and survey completion rates. The study also monitors physical fitness and health status through tests and questionnaires to better understand cachexia management. This involvement helps gather comprehensive data on patient health and the practicality of lifestyle interventions in pancreatic cancer care.
CONDITIONS
Brief Title
A First-in-Human Study of FID-022 in Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy or clinical features highly suggestive of it with confirmation expected early in the study
- Presentation consistent with resectable, borderline resectable, local, locally advanced, or metastatic disease
- May have had surgery or not
- Treatment plan likely includes systemic therapy for pancreatic cancer
- ECOG performance status of 0 to 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
You will not qualify if you...
- Pregnant or breastfeeding at enrollment
- Current use of tube feeding or total parenteral nutrition
- Presence of ascites or signs of decompensated disease
- History or evidence of bowel obstruction or gastrointestinal conditions limiting food intake
- Severe or uncontrolled psychiatric illness that would interfere with participation
- Other uncontrolled illnesses (e.g., infection, heart failure, liver failure) interfering with study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete dietary, symptom, quality of life, and physical activity surveys, undergo functional fitness tests, DEXA scans, and blood draws.
1 baseline visit (in-person)
Duration - Up to 9 months
Participants wear a Fitbit to monitor activity and complete a diet and physical activity preference survey at 9 months.
Continuous wearable monitoring with surveys at 9 months
Duration - 1 day
Participants complete a one-time survey assessing the integration of diet and exercise interventions into clinical workflow.
1 survey visit (can be remote or in-person)
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
S
Sanjukta Bhattacharjee
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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