Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT04207359
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Creatine Supplementation in Breast Cancer Survivors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2023-07
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 study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.
Detailed Description:
The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HSC20190610H | OTHER | UT Health Science Center San Antonio IRB | View |