Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer

Study Overview
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Brief Summary
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Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.

Official Title
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An Exploratory Study Evaluating the Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer With Biological Correlative Studies

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: HCP-Guided Exercise Training Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness and ability to participate in the study procedures Pathologically confirmed pancreatic cancer Candidate for neoadjuvant therapy followed by surgical resection with potentially curative intent. Note: There is no limitation on duration of neoadjuvant therapy. Planned to have at least 2 weeks after completing the last neoadjuvant therapy and surgery Over the age of 18 Ability to engage in physical activity as determined by physiatrist review after completion of the Physical Activity Readiness questionnaire (PAR-Q) exercise survey and chart review Agree to study blood draws and tissue collection Exclusion Criteria: Evidence of metastatic disease Inability to complete physical activity due to recent injury or surgery Uncontrolled heart disease limiting physical activity Participation in another interventional trial that excludes participation in this protocol Subjects who anticipate undergoing a procedure during the course of the trial that will render them unable to engage in physical activity for more than 48 hours Pregnant subjects Individuals who lack the capacity to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP-Guided Exercise<br>Participants will schedule twice-weekly in-person visits to conduct health care provider (HCP)-supervised exercise activity for a minimum of 30 minutes. At least 3 additional times per week, participants will conduct self-directed exercise at home. Activity and other outcomes will be monitored with an Actigraph Centrepoint Insight Watch. The HCP guided therapy will continue on a weekly basis for at least 2 weeks and up to a maximum of 4 weeks. | Behavioral: HCP-Guided Exercise Training Program<br>* Individually tailored exercise program consisting of aerobic training (5 days per week for a minimum of 30 minutes at moderate intensity) and strength training (2 days per week at moderate intensity). Two days per week the participant will receive their exercise program at NYU Langone Health. When at NYU, the training will be supervised by a physical therapist and will consist of the following: warm-up of 5 minutes, 30 minutes of aerobic exercise on either a stationary bike or treadmill at 60-70% of maximum heart rate. Following aerobic training, strength training will be carried out. Strength training will consist of 1 exercise per major muscle group, 8-12 reps, 1-3 sets at moderate intensity. The remaining three days a week the participant will perform aerobic training at home by exercising on a bicycle or by walking fast for a minimum of 30 mins at moderate intensity (60-70% of max HR).<br>|
| No Intervention: Control<br>Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention | Compliance with HCP exercise intervention is defined as successful completion of at least 150 minutes of weekly moderate-to-intense physical activity over a minimum of 2 weeks for every week of the prescribed intervention (2, 3 or 4 weeks). | Up to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Experience Adverse Events (AEs) | AEs defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. | Up to Week 4 | 
| Number of Participants who Experience an Event that Leads to Delay in Surgical Resection |  | Up to Week 4 | 
| Change in Number of Tumor-Infiltrating CD8-Positive T Cells | Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of cluster designation 8 (CD8)-positive T cells. | Baseline, Final Study Visit (Between Weeks 2-4) | 
| Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra | Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing Interleukin 15 Receptor Alpha Subunit (IL-15Ra). | Baseline, Final Study Visit (Between Weeks 2-4) | 
| Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB | Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing Granzyme B (GZMB). | Baseline, Final Study Visit (Between Weeks 2-4) | 
| Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3 | Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing cluster designation 3 (CD3). | Baseline, Final Study Visit (Between Weeks 2-4) | 
| Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry | Flow cytometry conducted on patient blood samples to assess number of circulating CD8-positive T cells expressing Interleukin 15 Receptor Alpha Subunit (IL-15Ra). | Baseline, Final Study Visit (Between Weeks 2-4) | 
| Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) | Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Moderate Activity is defined as between 3.00 and 5.99 metabolic equivalents (METs). Vigorous Activity is defined as at least 6.00 METs. MET is defined as the ratio of the work metabolic rate to the resting metabolic rate. | Up to Week 4 | 
| Time Spent in Sedentary Behavior | Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Sedentary Behavior is defined as less than 0.11 metabolic equivalents (METs). MET is defined as the ratio of the work metabolic rate to the resting metabolic rate. | Up to Week 4 | 
| Average Daily MET Rates | Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. MET is defined as the ratio of the work metabolic rate to the resting metabolic rate. Light intensity activities are defined as less than 3 METs, moderate intensity activities are defined as between 3 and 5.99 METs, and vigorous intensity activities are defined as 6 METs or greater. | Up to Week 4 | 
| Total Physical Activity Energy Expenditure | Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Expressed in kcal/day. | Up to Week 4 | 
| Minutes Spent in Rapid Eye Movement (REM) Sleep | Monitored using ActiGraph Centrepoint Insight Watch. | Up to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCP-Guided Exercise