Recruiting

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07249775

Conditions

Pancreatic Cancer

Cancer Cachexia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baseline Lifestyle and Symptom Assessment

Extended Lifestyle Monitoring

Feasibility Survey

Study Details

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.

Conditions

Pancreatic Cancer

Cancer Cachexia

Study ID

NCT07249775

Start date

Oct 8, 2025

Status verified date

Jan, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Pancreatic Cancer Patients

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

Oncology Clinicians

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

Interventions

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.

Extended Lifestyle Monitoring

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

Feasibility Survey

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

Primary outcome measure

  • AI Model Performance [ Time Frame: Up to 9 months ]
  • Survey Completion Rate [ Time Frame: Up to 9 months ]
  • Wearable Adherence [ Time Frame: Up to 9 months ]
  • Quality of Life Change [ Time Frame: Up to 9 months ]
  • Physical Activity Change [ Time Frame: Up to 9 months ]

Central Contacts and Locations

Central contacts

Sanjukta Bhattacharjee

813-745-0279Sanjukta.Bhattacharjee@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Sanjukta Bhattacharjee

813-745-0279Sanjukta.Bhattacharjee@moffitt.org

Principal Investigator:

Ghulam Rasool, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-01-28.