Status:
RECRUITING
Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to determine whether a virtually supervised resistance exercise (RE) intervention combined with protein supplementation (PS) is feasible in pancreatic cancer patients i...
Detailed Description
This research study is a randomized controlled trial that will assess feasibility and compare skeletal muscle mass, biomarkers of tissue wasting, physical function, and overall quality of life between...
Eligibility Criteria
Inclusion
- Non-metastatic pancreatic cancer patients initiating neoadjuvant chemotherapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease.
- Speak English or Spanish.
- Able to provide physician clearance to participate in the exercise program.
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity).
- Currently participate in less than or equal to 60 minutes of structured moderate or vigorous exercise/week.
- Does not smoke (no smoking during previous 12 months).
- Willing to travel to DFCI for assessments.
Exclusion
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease.
- Patients may not be receiving any other investigational agents.
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease.
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise.
- Patients expected to receive other cancer directed treatments during the study and assessment period.
- Participates in more than 60 minutes of structured moderate or vigorous exercise/week.
- Currently smokes.
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Is unable to travel to DFCI for assessments.
- Patients who are pregnant due to the unknown effects of exercise on the developing fetus.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05356117
Start Date
September 1 2022
End Date
August 15 2026
Last Update
February 20 2025
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215