Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)

Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy

Patients with pancreatic cancer receiving neoadjuvant chemotherapy often experience functional decline, treatment interruptions, and clinical deterioration, and these risks may be amplified when frailty is present.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Exercise; Physiological Reactivity to Cues
• Intervention / Treatment: Other: 36-session targeted physical exercise program delivered twice weekly

Detailed Description

Patients with pancreatic cancer receiving neoadjuvant chemotherapy often experience functional decline, treatment interruptions, and clinical deterioration, and these risks may be amplified when frailty is present. Frailty is increasingly recognized as an important predictor of worse treatment tolerance and perioperative outcomes in pancreatic cancer populations, including higher postoperative complication risk.

The proposed targeted physical therapy program is a supervised, individualized physical activity program designed to improve strength and functional performance using low-intensity, resistance-based exercise training. In this proposal, the study will evaluate the effects of the targeted physical exercise program in frail pancreatic cancer patients receiving neoadjuvant chemotherapy by generating key data on feasibility and safety and by providing preliminary estimates of change in functional outcomes to inform the design of a future, adequately powered study.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aslam Ejaz, MD; Phone Number: 312 996 6666; Email: aejaz@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥18 years

Diagnosis of pancreatic cancer that is potentially resectable per the treating clinical team's assessment.

Planned to receive or actively receiving neoadjuvant chemotherapy prior to surgery.

Frail or pre-frail as defined by the protocol-specified frailty assessment tool (e.g., Fried Frailty Phenotype; pre-frail = 1-2 criteria; frail => 3 criteria).

Able to provide written informed consent.

Medically appropriate to participate in supervised, symptom-limited exercise as determined by study screening and, if indicated, the treating clinician's input.

Able to complete study assessments and questionnaires in English or Spanish (using IRB-approved instruments/materials).

Exclusion Criteria:

Adults unable to consent.

Medical condition that, in the judgment of the investigator and/or treating clinician, makes exercise unsafe (e.g., unstable angina, uncontrolled arrhythmia, decompensated heart failure, uncontrolled severe pulmonary disease).

Any absolute contraindication to exercise participation/testing per institutional standards.

Severe symptoms or functional impairment that prevents safe participation despite program modification.

Inability to comply with the intervention schedule and study procedures despite reasonable scheduling accommodations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy; Eligible participants may be enrolled if they plan to initiate or are actively receiving neoadjuvant chemotherapy, provided they meet all inclusion criteria and have no contraindications to supervised exercise	Other: 36-session targeted physical exercise program delivered twice weekly; Participant will be enrolled for approximately 18-20 weeks (about 4-5 months). This includes a baseline assessment, participation in a 36-session targeted physical exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Defined as the number of participants enrolled divided by the number of eligible patients approached.	6 months
Retention rate	Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).	6 months
Adherence rate	Defined as the number of exercise sessions attended divided by 36, is summarized as a continuous measure and as the proportion of participants achieving a prespecified adherence threshold	6 months
Exercise-related adverse events (AEs) and serious adverse events (SAEs)	Summarized by frequency, severity, and relatedness to study participation, including any events requiring modification, temporary pause, or discontinuation of the exercise program.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3	To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Handgrip strength (kg), measured using a hand dynamometer (average of three trials in the dominant hand)	6 months
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3	To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Gait speed (seconds) over a standardized 15-foot walk test	6 months
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3	To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Frailty score and/or frailty classification measured using the protocol-specified frailty assessment tool.	6 months
Secondary patient-reported endpoints Part 1 of 3	- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).	6 months
Secondary patient-reported endpoints Part 2 of 3	- Patient activation/self-management assessed using the Patient Activation Measure (PAM).	6 months
Secondary patient-reported endpoints Part 3 of 3	- Pain severity (0-10 numeric rating scale) and pain location (descriptive).	6 months
Clinical endpoints obtained from routine care data Part 1 of 2	- Body composition (muscle mass) assessed using standard-of-care CT imaging when available at baseline and near the end of the intervention period.	6 months
Clinical endpoints obtained from routine care data Part 2 of 2	- Standard clinical laboratory markers obtained during routine care, including CA 19-9, albumin, creatinine, white blood cell count, and hemoglobin (baseline and post-intervention values when available).	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optional exploratory endpoint (biopsy sub study) Part 1 of 2	Change in expression of prespecified mature microRNAs from paired optional muscle biopsy specimens collected at baseline and post-intervention among participants who consent to this component.	1 year and 2 year
Optional exploratory endpoint (biopsy sub study) Part 2 of 2	Recurrence-free survival at 1 and 2 years, defined as time from surgery (or enrollment, if unresected) to documented recurrence, abstracted from the EMR.	1 year and 2 year

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2032

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 2026-0277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No