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.
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).
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.
Single group
36-session targeted physical exercise program delivered twice weekly
Other interventionParticipant 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
Recruitment rate
Defined as the number of participants enrolled divided by the number of eligible patients approached.
Retention rate
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
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.
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.
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)
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 8-foot walk test
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.
Secondary patient-reported endpoints Part 1 of 3
\- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
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