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NCT Number: NCT06423963

Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

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).

Recruiting

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Morgan Bean

CONTACT

[email protected]

813-745-1786

Nathan Parker, PhD

PRINCIPAL_INVESTIGATOR

Pamela Hodul, MD

PRINCIPAL_INVESTIGATOR

Sylvia Crowder, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Nutrition counseling

Behavioral

Participants will receive nutritional counseling with a registered dietician.

Resistance training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Examine exploratory outcomes and clinical characteristics

    Time frame: Up to 16 weeks

    The number of participants who demonstrate improvements in exploratory outcome measures.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan Bean

CONTACT

[email protected]

813-745-1786

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 21, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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