Effects of Creatine Supplementation in Breast Cancer Survivors

NCT ID: NCT04207359

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-03-07

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.

Conditions

Breast Cancer; Chemotherapy Effect; Muscle Weakness; Muscle Loss; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Creatine Supplement Group

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.

Group Type: EXPERIMENTAL

Creatine

Intervention Type: DIETARY_SUPPLEMENT

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.

Exercise Only Control Group

Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ThriveWell Cancer Foundation

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darpan I Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

UT Health San Antonio

San Antonio, Texas, United States

Countries

United States

References

Patel DI, Gonzalez A, Moon C, Serra M, Bridges PB, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N. Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study). JMIR Res Protoc. 2022 Apr 1;11(4):e26827. doi: 10.2196/26827.

Reference Type: DERIVED

PMID: 35363152 (View on PubMed)

Other Identifiers

HSC20190610H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS# 19-0028

Identifier Type: -

Identifier Source: org_study_id