Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
1 other identifier
interventional
26
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2024
CompletedFirst Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
February 9, 2026
February 1, 2026
2.5 years
April 22, 2024
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility and acceptability of PA/N and RT/N programs
The number of participants who complete T1 and T0 measures.
Up to 16 weeks
Secondary Outcomes (2)
Examine exploratory outcomes and clinical characteristics
Up to 16 weeks
Compare clinical and treatment outcomes
Up to 16 weeks
Study Arms (2)
Physical activity, nutrition counseling and monitoring group (PA/N)
EXPERIMENTALPhysical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
EXPERIMENTALInterventions
Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.
Participants will receive nutritional counseling with a registered dietician.
Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Parker, PhD
Moffitt Cancer Center
- PRINCIPAL INVESTIGATOR
Pamela Hodul, MD
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2024
First Posted
May 21, 2024
Study Start
February 9, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02