Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 36-session targeted physical exercise program delivered twice weekly (Other)
结局指标
主要结局
Recruitment rate
时间窗: 6 months
Defined as the number of participants enrolled divided by the number of eligible patients approached.
Retention rate
时间窗: 6 months
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
Adherence rate
时间窗: 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.
Exercise-related adverse events (AEs) and serious adverse events (SAEs)
时间窗: 6 months
Summarized by frequency, severity, and relatedness to study participation, including any events requiring modification, temporary pause, or discontinuation of the exercise program.
次要结局
- Secondary patient-reported endpoints Part 2 of 3(6 months)
- Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3(6 months)
- Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3(6 months)
- Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3(6 months)
- Secondary patient-reported endpoints Part 1 of 3(6 months)
- Secondary patient-reported endpoints Part 3 of 3(6 months)
- Clinical endpoints obtained from routine care data - Body composition(6 months)
- Clinical endpoints obtained from routine care data - CA 19-9(6 months)
- Clinical endpoints obtained from routine care data- Albumin (g/dL)(6 months)
- Clinical endpoints obtained from routine care data - Creatinine (mg/dL)(6 months)
- Clinical endpoints obtained from routine care data- White blood cell count (mcl)(6 months)
- Clinical endpoints obtained from routine care data- Hemoglobin(g/dL)(6 months)
- Secondary survival endpoints(1 year and 2 year)
研究者
Aslam Ejaz
Medical Doctor
University of Illinois at Chicago