Effects of Creatine Supplementation in Breast Cancer Survivors
The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2023
CompletedJuly 25, 2023
July 1, 2023
2.4 years
December 16, 2019
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Change in intramuscular creatine and altering energy storage.
From baseline to 12 weeks
Change in muscle cross sectional area
From baseline to 12 weeks
Study Arms (2)
Creatine Supplement Group
EXPERIMENTALParticipants 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.
Exercise Only Control Group
NO INTERVENTIONParticipants 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health San Antonio
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 35363152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darpan I Patel, PhD
UT Health San Antonio
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 20, 2019
Study Start
September 30, 2020
Primary Completion
March 7, 2023
Study Completion
March 7, 2023
Last Updated
July 25, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share