THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

Not Applicable

Recruiting

• Conditions: Breast Cancer Female; Muscle Weakness; Breast Cancer
• Interventions: Dietary Supplement: Creatine

• Registration Number: NCT06395506
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.

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 objective is to determine the effects of creatine in modulating strength and physical function in cancer survivors.

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-10
• Study Start: 2024-10-29
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Creatine Supplement Group	Creatine	Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol. Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Primary Outcome Measures

Name	Time	Method
Change in physical functional capacity in breast cancer survivors	baseline and 12 weeks	Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.
Change in strength in breast cancer survivors	baseline and 12 weeks	Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.

Secondary Outcome Measures

Name	Time	Method
Change intramuscular storage of creatine	baseline and 12 weeks	Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.
Change in the return of strength for breast cancer survivors with creatine + exercise	12 weeks	Breast cancer survivors who complete 12-weeks of exercise with creatine supplementation group who regained strength and physical function to that of women of similar age who never had cancer.
Change in body composition in cancer survivors	baseline and 12 weeks	Determine the change in body composition in breast cancer survivors by pre and post measurements of bone mass as well as lean vs fat mass via a DEXA scan.

Trial Locations

Locations (1)

The University of Texas Medical Branch, Galveston; 🇺🇸 Galveston, Texas, United States