Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05356117
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2022-04-15
Brief Title:
Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer The RE-BUILD Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy The RE-BUILD Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None