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Spots Global Cancer Trial Database for Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial

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Trial Identification

Brief Title: Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial

Official Title: Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial

Study ID: NCT05356117

Study Description

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 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

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 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Contact Details

Name: Christina M Dieli-Conwright, PhD, MPH

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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