Effects of Creatine Supplementation in Breast Cancer Survivors

Last updated: July 21, 2023
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Completed

Phase

N/A

Condition

Cancer

Breast Cancer

Sarcopenia

Treatment

Creatine

Clinical Study ID

NCT04207359
CTMS# 19-0028
HSC20190610H
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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) ≥30mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.

Exclusion

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 thangrade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairsor 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 forshort term use during the time of chemotherapy), androgens, progestational agents, orother appetite stimulants
  • Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
  • Currently taking creatine supplements

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Creatine
Phase:
Study Start date:
September 30, 2020
Estimated Completion Date:
March 07, 2023

Study 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.

Connect with a study center

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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