Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)
22. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Aslam Ejaz, MD
- Telefonnummer: 312 996 6666
- E-post: aejaz@uic.edu
Studer Kontakt Backup
- Navn: Zoey Zhou
- Telefonnummer: 312-996-6666
- E-post: zyzhou@uic.edu
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois Clinical Cancer Center
-
Ta kontakt med:
- Aslam Ejaz, MD
- Telefonnummer: 312-996-6666
- E-post: aejaz@uic.edu
-
Ta kontakt med:
- Zoey Zhou
- Telefonnummer: 312-996-6666
- E-post: zyzhou@uic.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: 6 months
|
Defined as the number of participants enrolled divided by the number of eligible patients approached.
|
6 months
|
|
Retention rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
6 months
|
|
Secondary patient-reported endpoints Part 2 of 3
Tidsramme: 6 months
|
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
|
6 months
|
|
Secondary patient-reported endpoints Part 3 of 3
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. juni 2026
Primær fullføring (Antatt)
30. april 2031
Studiet fullført (Antatt)
30. april 2032
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
15. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-0277
Plan for individuelle deltakerdata (IPD)
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JA
IPD-planbeskrivelse
with a publication in medical journal
IPD-delingstidsramme
starting 6 months after publication
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- CSR
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Nei
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