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

NCT05483075 | Completed

• 1 other identifier: 22-00289
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

HCP-Guided Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Participants who Experience Adverse Events (AEs)

  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

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

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

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

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

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

Study Arms (2)

HCP-Guided Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.

Interventions

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).

HCP-Guided Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health Ambulatory Care Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Oberstein, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: November 15, 2022
• Primary Completion: August 13, 2024
• Study Completion: August 14, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to paul.oberstein@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)