Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Behavioral: HCP-Guided Exercise Training Program
- Registration Number
- NCT05483075
- Lead Sponsor
- NYU Langone Health
- Brief Summary
Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HCP-Guided Exercise HCP-Guided Exercise Training Program 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.
- Primary Outcome Measures
Name Time Method Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention Up to Week 4 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).
- Secondary Outcome Measures
Name Time Method Change in Number of Tumor-Infiltrating CD8-Positive T Cells Baseline, Final Study Visit (Between Weeks 2-4) Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of cluster designation 8 (CD8)-positive T cells.
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra Baseline, Final Study Visit (Between Weeks 2-4) 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).
Minutes Spent in Rapid Eye Movement (REM) Sleep Up to Week 4 Monitored using ActiGraph Centrepoint Insight Watch.
Time Spent in Sedentary Behavior Up to Week 4 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.Total Physical Activity Energy Expenditure Up to Week 4 Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Expressed in kcal/day.
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 Expressing CD3 Baseline, Final Study Visit (Between Weeks 2-4) Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing cluster designation 3 (CD3).
Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry Baseline, Final Study Visit (Between Weeks 2-4) Flow cytometry conducted on patient blood samples to assess number of circulating CD8-positive T cells expressing Interleukin 15 Receptor Alpha Subunit (IL-15Ra).
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) Up to Week 4 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.Average Daily MET Rates Up to Week 4 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.Number of Participants who Experience Adverse Events (AEs) Up to Week 4 AEs defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB Baseline, Final Study Visit (Between Weeks 2-4) Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing Granzyme B (GZMB).
Trial Locations
- Locations (1)
NYU Langone Health Ambulatory Care Center
🇺🇸New York, New York, United States