Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)
Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Aslam Ejaz, MD
- Número de telefone: 312 996 6666
- E-mail: aejaz@uic.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment rate
Prazo: 6 months
|
Defined as the number of participants enrolled divided by the number of eligible patients approached.
|
6 months
|
|
Retention rate
Prazo: 6 months
|
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
|
6 months
|
|
Adherence rate
Prazo: 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
|
|
Exercise-related adverse events (AEs) and serious adverse events (SAEs)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
Prazo: 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 2 of 3
Prazo: 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 15-foot walk test |
6 months
|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3
Prazo: 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
Prazo: 6 months
|
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
6 months
|
|
Secondary patient-reported endpoints Part 2 of 3
Prazo: 6 months
|
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
|
6 months
|
|
Secondary patient-reported endpoints Part 3 of 3
Prazo: 6 months
|
- Pain severity (0-10 numeric rating scale) and pain location (descriptive).
|
6 months
|
|
Clinical endpoints obtained from routine care data Part 1 of 2
Prazo: 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 Part 2 of 2
Prazo: 6 months
|
- Standard clinical laboratory markers obtained during routine care, including CA 19-9, albumin, creatinine, white blood cell count, and hemoglobin (baseline and post-intervention values when available).
|
6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-0277
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