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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
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
University of Illinois Clinical Cancer Center
Chicago, Illinois, United States
RECRUITINGRecruitment rate
Defined as the number of participants enrolled divided by the number of eligible patients approached.
Time frame: 6 months
Retention rate
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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)
Time frame: 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 8-foot walk test
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Time frame: 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.
Time frame: 6 months
Secondary patient-reported endpoints Part 1 of 3
\- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
Time frame: 6 months
Secondary patient-reported endpoints Part 2 of 3
\- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
Time frame: 6 months
Secondary patient-reported endpoints Part 3 of 3
\- Pain severity (0-10 numeric rating scale) and pain location (descriptive).
Time frame: 6 months
Clinical endpoints obtained from routine care data - Body composition
\- Body composition (muscle mass) assessed using standard-of-care CT imaging when available at baseline and near the end of the intervention period.
Time frame: 6 months
Clinical endpoints obtained from routine care data - CA 19-9
\- Standard clinical laboratory markers obtained during routine care. Review of CA 19-9 (U/ml) at baseline and post-intervention values when available.
Time frame: 6 months
Clinical endpoints obtained from routine care data- Albumin (g/dL)
\- Standard clinical laboratory markers obtained during routine care. Review of Albumin (g/dL) at baseline and post-intervention values when available.
Time frame: 6 months
Clinical endpoints obtained from routine care data - Creatinine (mg/dL)
\- Standard clinical laboratory markers obtained during routine care. Review of Creatinine (mg/dL) at baseline and post-intervention values when available.
Time frame: 6 months
Clinical endpoints obtained from routine care data- White blood cell count (mcl)
\- Standard clinical laboratory markers obtained during routine care. Review of White blood cell count (mcl) at baseline and post-intervention values when available.
Time frame: 6 months
Clinical endpoints obtained from routine care data- Hemoglobin(g/dL)
\- Standard clinical laboratory markers obtained during routine care. Review of Hemoglobin(g/dL) at baseline and post-intervention values when available.
Time frame: 6 months
Secondary survival endpoints
Recurrence-free survival at 1 and 2 years, defined as time from surgery (or enrollment if unresected) to documented recurrence, abstracted from the EMR.
Time frame: 1 year and 2 year