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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HCP-Guided Exercise Training Program

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring HCP-Guided Exercise

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYU Langone Health Ambulatory Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HCP-Guided Exercise

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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

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.

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).

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).

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).

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).

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.

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.

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.

Total Physical Activity Energy Expenditure

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

Minutes Spent in Rapid Eye Movement (REM) Sleep

Monitored using ActiGraph Centrepoint Insight Watch.

Full Information

NCT ID

NCT05483075

First Posted

July 29, 2022

Last Updated

November 23, 2022

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT05483075

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

HCP-Guided Exercise

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HCP-Guided Exercise

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

HCP-Guided Exercise Training Program

Intervention Description

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 Outcome Measure Information:

Title

Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention

Description

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 Outcome Measure Information:

Title

Number of Participants who Experience Adverse Events (AEs)

Description

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

Title

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

Time Frame

Up to Week 4

Title

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

Description

Multiplex immune-fluorescence staining conducted on tumor tissue samples to assess number of cluster designation 8 (CD8)-positive T cells.

Time Frame