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Behavioral Intervention

Exercise and Nutrition Program for Pancreatic Cancer

N/A
Recruiting
Led By Nathan Parker, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
Must not have
Numeric pain rating scale greater than or equal to a 7 out of 10
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Summary

"This trial aims to see if an exercise and nutrition program before surgery for pancreatic cancer is possible and well-received by patients."

Who is the study for?
This trial is for individuals preparing for pancreatic cancer surgery. It's designed to see if a program of exercise and nutrition advice before the operation can help patients.
What is being tested?
The study tests a 'prehabilitation' program that includes physical activity, resistance training, and nutrition counseling to improve patient outcomes before pancreatic cancer surgery.
What are the potential side effects?
Since this trial involves exercise and nutritional guidance rather than medication, side effects may include muscle soreness from physical activity or changes in digestion due to diet adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My pancreatic cancer is confirmed and might be removable with surgery.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am currently receiving chemotherapy that includes both radiation and surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My pain level is at least 7 out of 10.
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I do not have unstable heart or lung conditions.
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I have a recent fracture or injury that stops me from doing radiation therapy.
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I have a muscle or joint disease that affects my ability to move.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and acceptability of PA/N and RT/N programs
Secondary outcome measures
Compare clinical and treatment outcomes
Examine exploratory outcomes and clinical characteristics

Trial Design

2Treatment groups
Experimental Treatment
Group I: Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)Experimental Treatment3 Interventions
Group II: Physical activity, nutrition counseling and monitoring group (PA/N)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Activity
2019
Completed Phase 3
~4780
Nutrition Counseling
2015
Completed Phase 2
~320
Resistance Training
2019
Completed Phase 2
~1190

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,514 Total Patients Enrolled
Nathan Parker, PhDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Pamela Hodul, MDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
213 Total Patients Enrolled
~9 spots leftby Feb 2025
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