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Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)

22 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

25

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Aslam Ejaz, MD
  • Numéro de téléphone: 312 996 6666
  • E-mail: aejaz@uic.edu

Sauvegarde des contacts de l'étude

  • Nom: Zoey Zhou
  • Numéro de téléphone: 312-996-6666
  • E-mail: zyzhou@uic.edu

Lieux d'étude

  • États-Unis
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Recrutement
        • University of Illinois Clinical Cancer Center
        • Contact:
          • Aslam Ejaz, MD
          • Numéro de téléphone: 312-996-6666
          • E-mail: aejaz@uic.edu
        • Contact:
          • Zoey Zhou
          • Numéro de téléphone: 312-996-6666
          • E-mail: zyzhou@uic.edu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Age ≥18 years
  2. Diagnosis of pancreatic cancer that is potentially resectable per the treating clinical team's assessment.
  3. Planned to receive or actively receiving neoadjuvant chemotherapy prior to surgery.
  4. 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).
  5. Able to provide written informed consent.
  6. Medically appropriate to participate in supervised, symptom-limited exercise as determined by study screening and, if indicated, the treating clinician's input.
  7. Able to complete study assessments and questionnaires in English or Spanish (using IRB- approved instruments/materials).

Exclusion Criteria:

  1. Adults unable to consent.
  2. 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).
  3. Any absolute contraindication to exercise participation/testing per institutional standards.
  4. Severe symptoms or functional impairment that prevents safe participation despite program modification.
  5. Inability to comply with the intervention schedule and study procedures despite reasonable scheduling accommodations.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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
Autre: 36-session targeted physical exercise program delivered twice weekly
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment rate
Délai: 6 months
Defined as the number of participants enrolled divided by the number of eligible patients approached.
6 months
Retention rate
Délai: 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)
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
Délai: 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
Délai: 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
Délai: 6 months
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
6 months
Secondary patient-reported endpoints Part 2 of 3
Délai: 6 months
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
6 months
Secondary patient-reported endpoints Part 3 of 3
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Illinois at Chicago

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juin 2026

Achèvement primaire (Estimé)

30 avril 2031

Achèvement de l'étude (Estimé)

30 avril 2032

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

15 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-0277

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

with a publication in medical journal

Délai de partage IPD

starting 6 months after publication

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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