Feasibility Of A Health Care Provider Guided Exercise Intervention Prior To Surgical Resection Of Pancreatic Cancer

Study Overview

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.

N/A

Pancreatic Cancer

BEHAVIORAL: HCP-Guided Exercise Training Program

22-00289

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-07-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-01
First Submitted that Met QC Criteria 2022-07-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-02
First Posted (ACTUAL) 2022-08-01	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HCP-Guided Exercise 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. Activi	BEHAVIORAL: HCP-Guided Exercise Training Program 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
NO_INTERVENTION: Control Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HCP-Guided Exercise

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. Activi

BEHAVIORAL: HCP-Guided Exercise Training Program

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

NO_INTERVENTION: Control

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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.	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	Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of cluster designation 8 (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	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).	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).	Baseline, Final Study Visit (Between Weeks 2-4)
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3	Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of CD8-positive T cells expressing cluster designation 3 (CD3).	Baseline, Final Study Visit (Between Weeks 2-4)
Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry	Flow cytometry conducted on patient blood samples to assess number of circulating CD8-positive T cells expressing Interleukin 15 Receptor Alpha Subunit (IL-15Ra).	Baseline, Final Study Visit (Between Weeks 2-4)
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)	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.	Up to Week 4
Time Spent in Sedentary Behavior	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.	Up to Week 4
Average Daily MET Rates	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.	Up to Week 4
Total Physical Activity Energy Expenditure	Monitored using the ActiGraph Centrepoint Insight Watch in conjunction with ActiLife software and validated algorithms. Expressed in kcal/day.	Up to Week 4
Minutes Spent in Rapid Eye Movement (REM) Sleep	Monitored using ActiGraph Centrepoint Insight Watch.	Up to Week 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Paul Oberstein, MD, NYU Langone Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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