Effects of Creatine Supplementation in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207359
• Other study ID #: CTMS# 19-0028
• Secondary ID: HSC20190610H
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: March 7, 2023

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect
• Exercise
• Muscle Loss
• Muscle Weakness

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	ThriveWell Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in strength in breast cancer survivors	Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.	From baseline to 12 weeks
Primary	Change in functional capacity in breast cancer survivors	Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).	From baseline to 12 weeks
Secondary	Change in intramuscular creatine and altering energy storage.	Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.	From baseline to 12 weeks
Secondary	Change in muscle cross sectional area	Magnetic resonance imaging will be used to capture the mid-thigh cross section.	From baseline to 12 weeks