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Creatine

Women who have never been diagnosed with cancer.

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.

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.

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.

Lisa Thibodeaux, RN,BSN

Rebecca Geck, MPH,APRN,CPT

Darpan Patel, PhD

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.

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.

This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors

Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.

Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.

Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation	NCT06395506	Breast Cancer Breast Cancer F... Muscle Weakness	Creatine	18 Years - 75 Years	The University of Texas Medical Branch, Galveston
THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation	NCT06395506	Breast Cancer Breast Cancer F... Muscle Weakness	Creatine	18 Years - 75 Years	The University of Texas Medical Branch, Galveston

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