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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Aslam Ejaz, MD
- 电话号码：312 996 6666
- 邮箱：aejaz@uic.edu
研究联系人备份
- 姓名：Zoey Zhou
- 电话号码：312-996-6666
- 邮箱：zyzhou@uic.edu
学习地点
-
-
Illinois
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Chicago、Illinois、美国、60612
- 招聘中
- University of Illinois Clinical Cancer Center
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接触：
- Aslam Ejaz, MD
- 电话号码：312-996-6666
- 邮箱：aejaz@uic.edu
-
接触：
- Zoey Zhou
- 电话号码：312-996-6666
- 邮箱：zyzhou@uic.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate
大体时间：6 months
|
Defined as the number of participants enrolled divided by the number of eligible patients approached.
|
6 months
|
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Retention rate
大体时间：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)
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
大体时间：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
大体时间：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
大体时间：6 months
|
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
6 months
|
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Secondary patient-reported endpoints Part 2 of 3
大体时间：6 months
|
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
|
6 months
|
|
Secondary patient-reported endpoints Part 3 of 3
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
大体时间：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
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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