Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT07647250 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0277
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physiological Reactivity to Cues; Physical Exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3

  6 months

• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3

  6 months

• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3

  6 months

• Secondary patient-reported endpoints Part 1 of 3

  6 months

• Secondary patient-reported endpoints Part 2 of 3

  6 months

Other Outcomes (2)

• Optional exploratory endpoint (biopsy sub study) Part 1 of 2

  1 year and 2 year

• Optional exploratory endpoint (biopsy sub study) Part 2 of 2

  1 year and 2 year

Study Arms (1)

physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy

OTHER

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

Interventions

36-session targeted physical exercise program delivered twice weekly OTHER

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

physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Aslam Ejaz, MD

CONTACT

312 996 6666; aejaz@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2032
• Last Updated: June 15, 2026

Record last verified: 2026-06