Cancer Cachexia, Pancreatic Cancer
Conditions
Brief 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.
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Florida Cancer Innovation Fund
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Change | Up to 9 months | Mean increase in weekly moderate-to-vigorous activity minutes. |
| AI Model Performance | Up to 9 months | Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use. |
| Survey Completion Rate | Up to 9 months | Percentage of patients completing all scheduled questionnaires. |
| Wearable Adherence | Up to 9 months | Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks. |
| Quality of Life Change | Up to 9 months | Mean change in FAACT total score from baseline to 9 months. |
Countries
United States
Contacts
CONTACTSanjukta Bhattacharjee
PRINCIPAL_INVESTIGATORGhulam Rasool, PhD
Moffitt Cancer Center
Outcome results
None listed