Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

NCT ID: NCT06423963

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2026-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical activity, nutrition counseling and monitoring group (PA/N)

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

Nutrition Counseling

Intervention Type BEHAVIORAL

Participants will receive nutritional counseling with a registered dietician.

Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

Nutrition Counseling

Intervention Type BEHAVIORAL

Participants will receive nutritional counseling with a registered dietician.

Resistance Training

Intervention Type BEHAVIORAL

Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

Interventions

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Physical Activity

Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

Intervention Type BEHAVIORAL

Nutrition Counseling

Participants will receive nutritional counseling with a registered dietician.

Intervention Type BEHAVIORAL

Resistance Training

Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Parker, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Pamela Hodul, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Morgan Bean

Role: CONTACT

Phone: 813-745-1786

Email: [email protected]

Facility Contacts

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Morgan Bean

Role: primary

Other Identifiers

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MCC-23088

Identifier Type: -

Identifier Source: org_study_id