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Observational Study for Pancreatic Cancer and Cachexia

This study is looking at ways to better understand and manage cancer-related weight loss and muscle wasting (cachexia) in people with pancreatic cancer. It's an observational study, meaning researchers will collect information about your health, lifestyle, and symptoms, rather than testing a new drug. They will use surveys, fitness tests, and wearable devices like a Fitbit. The goal is to develop an artificial intelligence (AI) tool to find cachexia early and to see how practical diet and exercise programs are for patients. You might be able to join if you are 18 or older and have been diagnosed with pancreatic cancer. The study aims to enroll 120 participants, but its current recruitment status is unclear.

Study design
This is an observational study aiming to enroll 120 participants. It is not testing a specific drug but rather collecting data to validate an AI model and assess intervention feasibility.
What's involved
You would complete dietary, symptom, and quality of life surveys, physical activity surveys, functional fitness tests, DEXA scans, and blood draws. You would also wear a monitoring device and complete a diet/physical activity preference survey at 9 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for up to 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07249775

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

Recruiting
Not specifiedAges 18+Observational
H. Lee Moffitt Cancer Center and Research Institute
~120 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Baseline Lifestyle and Symptom AssessmentExtended Lifestyle MonitoringFeasibility Survey

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AI Model Performance
Measured over Up to 9 months
+4 more outcomes measured

Conditions

Pancreatic Cancer
Cancer Cachexia

Explore related trials

Cancer CachexiaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ghulam Rasool, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Sanjukta Bhattacharjee
[email protected]
813-745-0279
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • AI Model PerformanceUp 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 RateUp to 9 months

    Percentage of patients completing all scheduled questionnaires.

  • Wearable AdherenceUp to 9 months

    Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.

  • Quality of Life ChangeUp to 9 months

    Mean change in FAACT total score from baseline to 9 months.

  • Physical Activity ChangeUp to 9 months

    Mean increase in weekly moderate-to-vigorous activity minutes.