Effects of Creatine Supplementation in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Muscle Weakness; Breast Cancer; Exercise; Chemotherapy Effect; Muscle Loss
• Interventions: Dietary Supplement: Creatine

• Registration Number: NCT04207359
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Study Start: 2020-09-30
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Creatine Supplement Group	Creatine	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 strength in breast cancer survivors	From baseline to 12 weeks	Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.
Change in functional capacity in breast cancer survivors	From baseline to 12 weeks	Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Secondary Outcome Measures

Name	Time	Method
Change in intramuscular creatine and altering energy storage.	From baseline to 12 weeks	Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.
Change in muscle cross sectional area	From baseline to 12 weeks	Magnetic resonance imaging will be used to capture the mid-thigh cross section.

Trial Locations

Locations (1)

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States