Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)
22 juni 2026 bijgewerkt door: Aslam Ejaz, University of Illinois at Chicago
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
25
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Aslam Ejaz, MD
- Telefoonnummer: 312 996 6666
- E-mail: aejaz@uic.edu
Studie Contact Back-up
- Naam: Zoey Zhou
- Telefoonnummer: 312-996-6666
- E-mail: zyzhou@uic.edu
Studie Locaties
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- Werving
- University of Illinois Clinical Cancer Center
-
Contact:
- Aslam Ejaz, MD
- Telefoonnummer: 312-996-6666
- E-mail: aejaz@uic.edu
-
Contact:
- Zoey Zhou
- Telefoonnummer: 312-996-6666
- E-mail: zyzhou@uic.edu
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy
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
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Recruitment rate
Tijdsspanne: 6 months
|
Defined as the number of participants enrolled divided by the number of eligible patients approached.
|
6 months
|
|
Retention rate
Tijdsspanne: 6 months
|
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
|
6 months
|
|
Exercise-related adverse events (AEs) and serious adverse events (SAEs)
Tijdsspanne: 6 months
|
Summarized by frequency, severity, and relatedness to study participation, including any events requiring modification, temporary pause, or discontinuation of the exercise program.
|
6 months
|
|
Adherence rate
Tijdsspanne: 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.
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
Tijdsspanne: 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) |
6 months
|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3
Tijdsspanne: 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. |
6 months
|
|
Secondary patient-reported endpoints Part 1 of 3
Tijdsspanne: 6 months
|
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
6 months
|
|
Secondary patient-reported endpoints Part 2 of 3
Tijdsspanne: 6 months
|
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
|
6 months
|
|
Secondary patient-reported endpoints Part 3 of 3
Tijdsspanne: 6 months
|
- Pain severity (0-10 numeric rating scale) and pain location (descriptive).
|
6 months
|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3
Tijdsspanne: 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 |
6 months
|
|
Clinical endpoints obtained from routine care data - Body composition
Tijdsspanne: 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.
|
6 months
|
|
Clinical endpoints obtained from routine care data - CA 19-9
Tijdsspanne: 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.
|
6 months
|
|
Clinical endpoints obtained from routine care data- Albumin (g/dL)
Tijdsspanne: 6 months
|
- Standard clinical laboratory markers obtained during routine care.
Review of Albumin (g/dL) at baseline and post-intervention values when available.
|
6 months
|
|
Clinical endpoints obtained from routine care data - Creatinine (mg/dL)
Tijdsspanne: 6 months
|
- Standard clinical laboratory markers obtained during routine care.
Review of Creatinine (mg/dL) at baseline and post-intervention values when available.
|
6 months
|
|
Clinical endpoints obtained from routine care data- White blood cell count (mcl)
Tijdsspanne: 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.
|
6 months
|
|
Clinical endpoints obtained from routine care data- Hemoglobin(g/dL)
Tijdsspanne: 6 months
|
- Standard clinical laboratory markers obtained during routine care.
Review of Hemoglobin(g/dL) at baseline and post-intervention values when available.
|
6 months
|
|
Secondary survival endpoints
Tijdsspanne: 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.
|
1 year and 2 year
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
Tijdsspanne: 1 year and 2 year
|
Change in expression of prespecified mature microRNAs from paired optional muscle biopsy specimens collected at baseline and post-intervention among participants who consent to this component.
|
1 year and 2 year
|
|
Optional exploratory endpoint (biopsy sub study) Part 2 of 2
Tijdsspanne: 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.
|
1 year and 2 year
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 juni 2026
Primaire voltooiing (Geschat)
30 april 2031
Studie voltooiing (Geschat)
30 april 2032
Studieregistratiedata
Eerst ingediend
4 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-0277
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
with a publication in medical journal
IPD-tijdsbestek voor delen
starting 6 months after publication
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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