Recruiting NCT06423963
Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Activity, Nutrition Counseling, Resistance Training.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Behavioral Physical Activity
Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts. - Behavioral Nutrition Counseling
Participants will receive nutritional counseling with a registered dietician. - Behavioral Resistance Training
Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.
Primary outcome measures
- Feasibility and acceptability of PA/N and RT/N programs [Time frame: Up to 16 weeks]
Secondary outcome measures (2)
- Examine exploratory outcomes and clinical characteristics [Time frame: Up to 16 weeks]
- Compare clinical and treatment outcomes [Time frame: Up to 16 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT06423963 · MCC-23088