Physiological Reactivity to CuesGI-07NCT07647250
Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
A study testing 36-session targeted physical exercise program delivered twice weekly in people with Physiological Reactivity to Cues and Physical Exercise, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiological Reactivity to Cues, Physical Exercise
- What is being tested?
- 36-session targeted physical exercise program delivered twice weekly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to 30 Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Clinical Cancer Center
Chicago, Illinois, 60612
Aslam Ejaz, MD, 312-996-6666, aejaz@uic.edu
Zoey Zhou, 312-996-6666, zyzhou@uic.edu
About this study
Official title: Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail 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.
Read the 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.
- Being tested
- 36-session targeted physical exercise program delivered twice weekly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
36-session targeted physical exercise program delivered twice weeklyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 36-session targeted physical exercise program delivered twice weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Defined as the number of participants enrolled divided by the number of eligible patients approached.
Measured: 6 months
Retention rate
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (13)
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)
Measured: 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
Measured: 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.
Measured: 6 months
Secondary patient-reported endpoints Part 1 of 3
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
Measured: 6 months
Secondary patient-reported endpoints Part 2 of 3
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
Measured: 6 months
Secondary patient-reported endpoints Part 3 of 3
- Pain severity (0-10 numeric rating scale) and pain location (descriptive).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start22 Jun 2026
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Reactivity to CuesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslam Ejaz, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647250
- Sponsor's protocol ID
- 2026-0277
- Acronym
- GI-07
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: with a publication in medical journal
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07647250
- Acronym / sponsor ID
- GI-07 / 2026-0277
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy | Other | Other: 36-session targeted physical exercise program delivered twice weeklyEligible 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 36-session targeted physical exercise program delivered twice weeklyParticipant 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 | Other | physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy |
Primary outcome
Recruitment rate
Time frame: 6 months
Defined as the number of participants enrolled divided by the number of eligible patients approached.
Retention rate
Time frame: 6 months
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
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.
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.
13 secondary outcomes
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
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
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
Secondary patient-reported endpoints Part 1 of 3
Time frame: 6 months
Secondary patient-reported endpoints Part 2 of 3
Time frame: 6 months
Secondary patient-reported endpoints Part 3 of 3
Time frame: 6 months
Clinical endpoints obtained from routine care data - Body composition
Time frame: 6 months
Clinical endpoints obtained from routine care data - CA 19-9
Time frame: 6 months
Clinical endpoints obtained from routine care data- Albumin (g/dL)
Time frame: 6 months
Clinical endpoints obtained from routine care data - Creatinine (mg/dL)
Time frame: 6 months
Clinical endpoints obtained from routine care data- White blood cell count (mcl)
Time frame: 6 months
Clinical endpoints obtained from routine care data- Hemoglobin(g/dL)
Time frame: 6 months
Secondary survival endpoints
Time frame: 1 year and 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. with a publication in medical journal
Related trials for Physiological Reactivity to Cues
Active, not recruiting
Physiological Reaction After Food Intake
Physiological Reactivity to Cues
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 36-session targeted physical exercise program delivered twice weekly in people with Physiological Reactivity to Cues and Physical Exercise, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslam Ejaz, MD (312 996 6666, aejaz@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.