NCT06423963
Recruiting
N/A
Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country26 target enrollmentFebruary 9, 2024
ConditionsPancreatic Cancer
Overview
- Phase
- N/A
- Intervention
- Physical Activity
- Conditions
- Pancreatic Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Feasibility and acceptability of PA/N and RT/N programs
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Physical activity, nutrition counseling and monitoring group (PA/N)
Intervention: Physical Activity
Physical activity, nutrition counseling and monitoring group (PA/N)
Intervention: Nutrition Counseling
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Intervention: Physical Activity
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Intervention: Nutrition Counseling
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Intervention: Resistance Training
Outcomes
Primary Outcomes
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
- Examine exploratory outcomes and clinical characteristics(Up to 16 weeks)
- Compare clinical and treatment outcomes(Up to 16 weeks)
Study Sites (1)
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