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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483075
• Other study ID #: 22-00289
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Paul Oberstein, MD
• Phone: 212-731-6120
• Email: paul.oberstein[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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).

Locations

Country	Name	City	State
United States	NYU Langone Health Ambulatory Care Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants who Experience an Event that Leads to Delay in Surgical Resection		Up to Week 4
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Minutes Spent in Rapid Eye Movement (REM) Sleep	Monitored using ActiGraph Centrepoint Insight Watch.	Up to Week 4