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

• ClinicalTrials.gov Identifier: NCT05483075
• Recruitment Status: Recruiting
• First Posted: August 1, 2022
• Last Update Posted: November 29, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: July 29, 2022
• First Posted Date: August 1, 2022
• Last Update Posted Date: November 29, 2022
• Actual Study Start Date: November 15, 2022
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2022)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 29, 2022)

• 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.
• 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 [ 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.
• 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).
• 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).
• 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).
• 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).
• 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.
• 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.
• 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.
• 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.
• Minutes Spent in Rapid Eye Movement (REM) Sleep [ Time Frame: Up to Week 4 ]
  Monitored using ActiGraph Centrepoint Insight Watch.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Pancreatic Cancer

Intervention

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 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).

Study Arms

• 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. 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.

  Intervention: Behavioral: HCP-Guided Exercise Training Program
• No Intervention: Control
  Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Paul Oberstein, MD; 212-731-6120; paul.oberstein@nyulangone.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05483075
• Other Study ID Numbers: 22-00289
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:

Paul Oberstein 212-731-6120 paul.oberstein@nyulangone.org

The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul Oberstein, MD; NYU Langone Medical Center

• PRS Account: NYU Langone Health
• Verification Date: November 2022