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Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial
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 initiating chemotherapy and if it will improve skeletal muscle mass. 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
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 three groups - exercise and supplement, exercise-only, and attention control. This study intends to evaluate whether resistance exercise and protein supplementation can improve skeletal muscle mass as well as decrease tissue wasting biomarkers in the blood, among patients undergoing chemotherapy for pancreatic cancer as there is some evidence that pancreatic cancer patients can experience muscle wasting while on chemotherapy. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
September 1, 2022
Primary Completion Date
January 31, 2027
Completion Date
August 15, 2027
Last Updated
February 19, 2026
45
ESTIMATED participants
Resistance Training (RT) and Protein Supplementation (PS)
BEHAVIORAL
Resistance Training (RT)
BEHAVIORAL
Attention Control (AC
BEHAVIORAL
Christina M Dieli-Conwright, PhD, MPH
CONTACT
Lead Sponsor
Dana-Farber Cancer Institute
NCT04550494
NCT05053971
Data Source & Attribution
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