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Trial Title:
Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
NCT ID:
NCT06423963
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Physical Activity
Description:
Each participant will receive a Fitbit device with instruction and encouragement to
self-monitor physical activity using step counts.
Arm group label:
Physical activity, nutrition counseling and monitoring group (PA/N)
Arm group label:
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Intervention type:
Behavioral
Intervention name:
Nutrition Counseling
Description:
Participants will receive nutritional counseling with a registered dietician.
Arm group label:
Physical activity, nutrition counseling and monitoring group (PA/N)
Arm group label:
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
Intervention type:
Behavioral
Intervention name:
Resistance Training
Description:
Participants will engage in progressive, full-body resistance training based on American
College of Sports Medicine (ACSM) guidelines.
Arm group label:
Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Morgan Bean
Phone:
813-745-1786
Email:
morgan.bean@moffitt.org
Investigator:
Last name:
Nathan Parker, PhD
Email:
Principal Investigator
Investigator:
Last name:
Pamela Hodul, MD
Email:
Principal Investigator
Investigator:
Last name:
Sylvia Crowder, PhD
Email:
Sub-Investigator
Start date:
February 8, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06423963
