Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

May 5, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Pamela Hodul, MD
        • Contact:
        • Principal Investigator:
          • Nathan Parker, PhD
        • Sub-Investigator:
          • Sylvia Crowder, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection
  • Ability to read and speak English

Exclusion Criteria:

  • Regular engagement in RT (2x/week targeting all major muscle groups)
  • Screen failure for exercise safety based on PAR-Q
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
  • Numeric pain rating scale greater than or equal to a 7 out of 10
  • Myopathic or rheumatologic disease that impacts physical function

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity, nutrition counseling and monitoring group (PA/N)
Behavioral: Physical Activity
Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.
Behavioral: Nutrition Counseling
Participants will receive nutritional counseling with a registered dietician.
Experimental: Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Behavioral: Physical Activity
Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.
Behavioral: Nutrition Counseling
Participants will receive nutritional counseling with a registered dietician.
Behavioral: Resistance Training
Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability of PA/N and RT/N programs
Time Frame: Up to 16 weeks
The number of participants who complete T1 and T0 measures.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine exploratory outcomes and clinical characteristics
Time Frame: Up to 16 weeks
The number of participants who demonstrate improvements in exploratory outcome measures.
Up to 16 weeks
Compare clinical and treatment outcomes
Time Frame: Up to 16 weeks
Chi-Square testing will be used to determine if there's a significant difference in outcomes between the treatment group and a usual care comparison group.
Up to 16 weeks

Collaborators and Investigators

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Pamela Hodul, MD, Moffitt Cancer Center
  • Principal Investigator: Nathan Parker, PhD, Moffitt Cancer Center

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 Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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