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NCT Number: NCT07647250

Pilot Study to Evaluate Targeted Physical Activity Among 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.

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Key information

Conditions

Physiological Reactivity to Cues Behavior Motor Activity Physical Exercise

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Recruitment rate

    Time frame: 6 months

    Defined as the number of participants enrolled divided by the number of eligible patients approached.

  2. Retention rate

    Time frame: 6 months

    Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).

  3. Adherence rate

    Time frame: 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.

  4. Exercise-related adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 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 outcomes

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

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 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.

  4. Secondary patient-reported endpoints Part 1 of 3

    Time frame: 6 months

    • Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).

  5. Secondary patient-reported endpoints Part 2 of 3

    Time frame: 6 months

    • Patient activation/self-management assessed using the Patient Activation Measure (PAM).

  6. Secondary patient-reported endpoints Part 3 of 3

    Time frame: 6 months

    • Pain severity (0-10 numeric rating scale) and pain location (descriptive).

  7. Clinical endpoints obtained from routine care data - Body composition

    Time frame: 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.

  8. Clinical endpoints obtained from routine care data - CA 19-9

    Time frame: 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.

  9. Clinical endpoints obtained from routine care data- Albumin (g/dL)

    Time frame: 6 months

    • Standard clinical laboratory markers obtained during routine care. Review of Albumin (g/dL) at baseline and post-intervention values when available.

  10. Clinical endpoints obtained from routine care data - Creatinine (mg/dL)

    Time frame: 6 months

    • Standard clinical laboratory markers obtained during routine care. Review of Creatinine (mg/dL) at baseline and post-intervention values when available.

  11. Clinical endpoints obtained from routine care data- White blood cell count (mcl)

    Time frame: 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.

  12. Clinical endpoints obtained from routine care data- Hemoglobin(g/dL)

    Time frame: 6 months

    • Standard clinical laboratory markers obtained during routine care. Review of Hemoglobin(g/dL) at baseline and post-intervention values when available.

  13. Secondary survival endpoints

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslam Ejaz, MD

CONTACT

[email protected]

312 996 6666

Zoey Zhou

CONTACT

[email protected]

312-996-6666

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Acronym: GI-07

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jun 15, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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