Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
NCT ID: NCT05356117
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2022-09-01
2026-08-15
Brief Summary
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The names of the study interventions involved in this study are:
* Resistance training and protein supplement intake (RE + PS)
* Resistance training (RE)
* Attention control (AC), home-based stretching
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Detailed Description
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The research study procedures include: screening for eligibility and study treatment including extensive evaluations of participant fitness and body composition including CT, blood tests, fitness and strength assessments, and surveys at study entry, half-way through the intervention, and follow-up visit.
Participants in this study will be randomly assigned to one of three groups: 1) Resistance exercise and protein supplementation (RE+ PS), 2) Resistance exercise (RE), or 3) Attention control (AC).
This research study is expected to last for up to a total of 4 months.
It is expected that about 45 people will take part in this research study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Resistance Training (RT) and Protein Supplementation (PS)
Participants will be randomly assigned to the Resistance Training (RT) and Protein Supplementation (PS) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week with daily protein supplementation for the duration of their chemotherapy with a maximum of 16-weeks of exercise. Exercises will be tailored to the participants' fitness levels.
Sessions will last \~60 minutes including 5-minute warm-up and 5-minute cool-down.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
Resistance Training (RT) and Protein Supplementation (PS)
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
Resistance Training (RT)
Participants will be randomly assigned to the Resistance Training (RT) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week. Exercises will be tailored to the participants' fitness levels.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
Resistance Training (RT)
Aerobic and resistance exercise
Attention Control (AC)
Participants will be randomly assigned to the Attention Control (AC) group and receive instruction on a home-based, 3 days a week stretching program.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
The attention control group will be given the option to participate in the exercise intervention after their treatment is completed, with a cap of a 16-week period.
Attention Control (AC
Stretching
Interventions
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Resistance Training (RT) and Protein Supplementation (PS)
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
Resistance Training (RT)
Aerobic and resistance exercise
Attention Control (AC
Stretching
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christina Dieli-Conwright, PhD
Principal Investigator
Principal Investigators
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Christina M Dieli-Conwright, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Christina M Dieli-Conwright, PhD, MPH
Role: CONTACT
Facility Contacts
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PhD, MPH
Role: backup
Other Identifiers
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21-506
Identifier Type: -
Identifier Source: org_study_id
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