NCT06395506 · The University of Texas Medical Branch, Galveston
THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
(THRIVE)
What this study is about
The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.
View original scientific description
The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Breast Cancer Group)
- Age 18-75 years of age
- Diagnosis of breast cancer requiring chemotherapy
- Recent (within 6 months) completion of chemotherapy
- Willing to attend 3 virtual-based 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
- (Breast Cancer Group)
- 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 greater than 2+
- Currently undergoing chemotherapy treatment for cancer
- 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 become pregnant during the study
- Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), 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
- Lack of availability to a smartphone and/or internet Inclusion Criteria (Healthy Age-matched Control Group)
- Age 18-75 years of age
- Have never been diagnosed with cancer
- Willing to provide consent to participate in this study Exclusion Criteria (Healthy Age-matched Control Group)
- 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 greater than 2+
- History of cancer diagnosis
- 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 currently taking prescribed medication to prepare for pregnancy (i.e. hormonal therapy for IVF)
- Recent (within one month) treatment with corticosteroids
- Recent (within one month) use of appetite stimulants or appetite suppressants
- 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
- Diagnosed Bipolar Disorder or MDQ score indicative of bipolar disorder or Neurological disorders
- Uncontrolled diabetes (A1c of 6.5% or higher)
- Currently taking creatine supplements
- Lack of availability to a smartphone and/or internet
Where
- Galveston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations