Clinical trial NCT05483075: Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: HCP-Guided Exercise
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

1. Willingness and ability to participate in the study procedures
2. Pathologically confirmed pancreatic cancer
3. Candidate for neoadjuvant therapy followed by surgical resection with potentially curative intent. Note: There is no limitation on duration of neoadjuvant therapy.
4. Planned to have at least 2 weeks after completing the last neoadjuvant therapy and surgery
5. Over the age of 18
6. 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
7. Agree to study blood draws and tissue collection

Exclusion Criteria:

1. Evidence of metastatic disease
2. Inability to complete physical activity due to recent injury or surgery
3. Uncontrolled heart disease limiting physical activity
4. Participation in another interventional trial that excludes participation in this protocol
5. 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
6. Pregnant subjects
7. Individuals who lack the capacity to consent

Primary outcomes:
measure: Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention
timeFrame: Up to Week 4
Secondary outcomes:
measure: Number of Participants who Experience Adverse Events (AEs)
timeFrame: Up to Week 4
measure: Number of Participants who Experience an Event that Leads to Delay in Surgical Resection
timeFrame: Up to Week 4
measure: Change in Number of Tumor-Infiltrating CD8-Positive T Cells
timeFrame: Baseline, Final Study Visit (Between Weeks 2-4)
measure: Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra
timeFrame: Baseline, Final Study Visit (Between Weeks 2-4)
measure: Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB
timeFrame: Baseline, Final Study Visit (Between Weeks 2-4)
measure: Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3
timeFrame: Baseline, Final Study Visit (Between Weeks 2-4)
measure: Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry
timeFrame: Baseline, Final Study Visit (Between Weeks 2-4)
measure: Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: Up to Week 4
measure: Time Spent in Sedentary Behavior
timeFrame: Up to Week 4
measure: Average Daily MET Rates
timeFrame: Up to Week 4
measure: Total Physical Activity Energy Expenditure
timeFrame: Up to Week 4
measure: Minutes Spent in Rapid Eye Movement (REM) Sleep
timeFrame: Up to Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health Ambulatory Care Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Paul Oberstein, MD
role: PRINCIPAL_INVESTIGATOR
References: