Pancreatic CancerNCT05483075
Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer
A study testing HCP-Guided Exercise Training Program in people with Pancreatic Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HCP-Guided Exercise Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Health Ambulatory Care Center
New York, New York, 10016
About this study
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
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
- Being tested
- HCP-Guided Exercise Training Program
- Keywords
- HCP-Guided Exercise
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP-Guided Exercise Training ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to Week 4
Secondary outcomes (12)
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.
Measured: Up to Week 4
Number of Participants who Experience an Event that Leads to Delay in Surgical Resection
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 4
Minutes Spent in Rapid Eye Movement (REM) Sleep
Monitored using ActiGraph Centrepoint Insight Watch.
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Nov 2022
- Primary completion13 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Oberstein, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483075
- Sponsor's protocol ID
- 22-00289
- Status last verified
- May 2025
- First submitted
- 29 Jul 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05483075
- Acronym / sponsor ID
- 22-00289
- Conditions
- Pancreatic Cancer
- Keywords
- HCP-Guided Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP-Guided Exercise | Experimental | Behavioral: HCP-Guided Exercise Training ProgramParticipants 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. |
| Control | No intervention | –Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCP-Guided Exercise Training ProgramIndividually 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). | Behavioural | HCP-Guided Exercise |
Primary outcome
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).
12 secondary outcomes
Number of Participants who Experience Adverse Events (AEs)
Time frame: Up to Week 4
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)
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra
Time frame: Baseline, Final Study Visit (Between Weeks 2-4)
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB
Time frame: Baseline, Final Study Visit (Between Weeks 2-4)
Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3
Time frame: 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
Time frame: Baseline, Final Study Visit (Between Weeks 2-4)
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Up to Week 4
Time Spent in Sedentary Behavior
Time frame: Up to Week 4
Average Daily MET Rates
Time frame: Up to Week 4
Total Physical Activity Energy Expenditure
Time frame: Up to Week 4
Minutes Spent in Rapid Eye Movement (REM) Sleep
Time frame: Up to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Oberstein, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCP-Guided Exercise Training Program in people with Pancreatic Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.