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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Cancer Cachexia; Pancreatic Cancer

Treatments: Other: Extended Lifestyle Monitoring; Other: Feasibility Survey; Other: Baseline Lifestyle and Symptom Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07249775

MCC-23812

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Pancreatic Cancer Patients

Description:

Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.

Treatment:

Other: Baseline Lifestyle and Symptom Assessment

Other: Extended Lifestyle Monitoring

Oncology Clinicians

Description:

Medical oncologists, APPs, dietitians involved in pancreatic cancer care.

Treatment:

Other: Feasibility Survey