Breast Cancer Clinical Trial

Effects of Creatine Supplementation in Breast Cancer Survivors

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Age 18-75 years of age
Recent (within 6 months) completion of chemotherapy
Willing to attend 3 virtual exercise sessions per week
Able to take oral medications
Participant is willing and able to provide consent to participating in the study
Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.

Exclusion Criteria:

Physical indications where performing exercise may be limited and/or contraindicated
Poorly-controlled hypertension (blood pressure > 160/95mmHg)
Current tobacco use (within 6 months)
Anabolic steroids use
Pitting edema
Currently undergoing chemotherapy
History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation).
Pregnant or plan to get pregnant during the study
Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, or other appetite stimulants
Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
Currently taking creatine supplements

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT04207359

Recruitment Status:

Recruiting

Sponsor:

The University of Texas Health Science Center at San Antonio

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There is 1 Location for this study

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UT Health San Antonio
San Antonio Texas, 78229, United States More Info
Darpan Patel, PhD
Contact
210-567-0362
[email protected]
Darpan I Patel, PhD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT04207359

Recruitment Status:

Recruiting

Sponsor:


The University of Texas Health Science Center at San Antonio

How clear is this clinincal trial information?

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