Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy

Официальное название

Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Recruitment rate [Срок оценки: 6 months]
• Retention rate [Срок оценки: 6 months]
• Adherence rate [Срок оценки: 6 months]
• Exercise-related adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3 [Срок оценки: 6 months]
• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3 [Срок оценки: 6 months]
• Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3 [Срок оценки: 6 months]
• Secondary patient-reported endpoints Part 1 of 3 [Срок оценки: 6 months]
• Secondary patient-reported endpoints Part 2 of 3 [Срок оценки: 6 months]
• Secondary patient-reported endpoints Part 3 of 3 [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data - Body composition [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data - CA 19-9 [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data- Albumin (g/dL) [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data - Creatinine (mg/dL) [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data- White blood cell count (mcl) [Срок оценки: 6 months]
• Clinical endpoints obtained from routine care data- Hemoglobin(g/dL) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Illinois Clinical Cancer Center — Chicago

Идентификаторы

NCT: NCT07647250 · 2026-0277

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗