Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423963
• Other study ID #: MCC-23088
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Morgan Bean
• Phone: 813-745-1786
• Email: morgan.bean[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Physical Activity
Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.
• Nutrition Counseling
Participants will receive nutritional counseling with a registered dietician.
• Resistance Training
Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Examine exploratory outcomes and clinical characteristics	The number of participants who demonstrate improvements in exploratory outcome measures.	Up to 16 weeks
Secondary	Compare clinical and treatment outcomes	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.	Up to 16 weeks