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

NYU Langone Health16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

HCP-Guided Exercise Training ProgramBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health Ambulatory Care Center

New York, New York, United States

Outcomes

Primary Outcomes

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).

Time frame: Up to Week 4

Secondary Outcomes

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.

Time frame: Up to Week 4

Number of Participants who Experience an Event that Leads to Delay in Surgical Resection

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: Baseline, Final Study Visit (Between Weeks 2-4)

Data from ClinicalTrials.gov

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