Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Behavioral: Physical Activity; Behavioral: Nutrition Counseling; Behavioral: Resistance Training

• Registration Number: NCT06423963
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-09
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity, nutrition counseling and monitoring group (PA/N)	Nutrition Counseling	-
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)	Resistance Training	-
Physical activity, nutrition counseling and monitoring group (PA/N)	Physical Activity	-
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)	Physical Activity	-
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)	Nutrition Counseling	-

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of PA/N and RT/N programs	Up to 16 weeks	The number of participants who complete T1 and T0 measures.

Secondary Outcome Measures

Name	Time	Method
Examine exploratory outcomes and clinical characteristics	Up to 16 weeks	The number of participants who demonstrate improvements in exploratory outcome measures.
Compare clinical and treatment outcomes	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States