Physical Exercise, Physiological Reactivity to Cues
Conditions
Brief summary
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.
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.
Interventions
OTHER36-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
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Study focus on the feasibility and safety of delivering a 36-session targeted physical exercise program to frail adults with pancreatic cancer receiving neoadjuvant chemotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Diagnosis of pancreatic cancer that is potentially resectable per the treating clinical team's assessment. 3. Planned to receive or actively receiving neoadjuvant chemotherapy prior to surgery. 4. 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). 5. Able to provide written informed consent. 6. Medically appropriate to participate in supervised, symptom-limited exercise as determined by study screening and, if indicated, the treating clinician's input. 7. Able to complete study assessments and questionnaires in English or Spanish (using IRB- approved instruments/materials).
Exclusion criteria
1. Adults unable to consent. 2. 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). 3. Any absolute contraindication to exercise participation/testing per institutional standards. 4. Severe symptoms or functional impairment that prevents safe participation despite program modification. 5. Inability to comply with the intervention schedule and study procedures despite reasonable scheduling accommodations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | Defined as the number of participants enrolled divided by the number of eligible patients approached. |
| Retention rate | 6 months | Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window). |
| Adherence rate | 6 months | 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) | 6 months | Summarized by frequency, severity, and relatedness to study participation, including any events requiring modification, temporary pause, or discontinuation of the exercise program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3 | 6 months | 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 | 6 months | 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 | 6 months | 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 | 6 months | \- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9). |
| Secondary patient-reported endpoints Part 2 of 3 | 6 months | \- Patient activation/self-management assessed using the Patient Activation Measure (PAM). |
| Secondary patient-reported endpoints Part 3 of 3 | 6 months | \- Pain severity (0-10 numeric rating scale) and pain location (descriptive). |
| Clinical endpoints obtained from routine care data - Body composition | 6 months | \- Body composition (muscle mass) assessed using standard-of-care CT imaging when available at baseline and near the end of the intervention period. |
| Clinical endpoints obtained from routine care data - CA 19-9 | 6 months | \- Standard clinical laboratory markers obtained during routine care. Review of CA 19-9 (U/ml) at baseline and post-intervention values when available. |
| Clinical endpoints obtained from routine care data- Albumin (g/dL) | 6 months | \- Standard clinical laboratory markers obtained during routine care. Review of Albumin (g/dL) at baseline and post-intervention values when available. |
| Clinical endpoints obtained from routine care data - Creatinine (mg/dL) | 6 months | \- Standard clinical laboratory markers obtained during routine care. Review of Creatinine (mg/dL) at baseline and post-intervention values when available. |
| Clinical endpoints obtained from routine care data- White blood cell count (mcl) | 6 months | \- Standard clinical laboratory markers obtained during routine care. Review of White blood cell count (mcl) at baseline and post-intervention values when available. |
| Clinical endpoints obtained from routine care data- Hemoglobin(g/dL) | 6 months | \- Standard clinical laboratory markers obtained during routine care. Review of Hemoglobin(g/dL) at baseline and post-intervention values when available. |
| Secondary survival endpoints | 1 year and 2 year | Recurrence-free survival at 1 and 2 years, defined as time from surgery (or enrollment if unresected) to documented recurrence, abstracted from the EMR. |
Countries
United States
Contacts
CONTACTAslam Ejaz, MD
CONTACTZoey Zhou
Outcome results
None listed