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Completed

NCT Number: NCT05483075

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

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

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health Ambulatory Care Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP-Guided Exercise Training Program

Behavioral

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).

Primary outcomes

  1. Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention

    Time frame: 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 outcomes

  1. Number of Participants who Experience Adverse Events (AEs)

    Time frame: 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.

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

    Time frame: Up to Week 4

  3. Change in Number of Tumor-Infiltrating CD8-Positive T Cells

    Time frame: 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.

  4. Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra

    Time frame: 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).

  5. Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB

    Time frame: 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).

  6. Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3

    Time frame: 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).

  7. Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry

    Time frame: 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).

  8. Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)

    Time frame: 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.

  9. Time Spent in Sedentary Behavior

    Time frame: 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.

  10. Average Daily MET Rates

    Time frame: 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.

  11. Total Physical Activity Energy Expenditure

    Time frame: Up to Week 4

    Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Expressed in kcal/day.

  12. Minutes Spent in Rapid Eye Movement (REM) Sleep

    Time frame: Up to Week 4

    Monitored using ActiGraph Centrepoint Insight Watch.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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