Recruiting
THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
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.
ClinicalTrials.gov IDNCT06395506
PhaseNA
Enrollment60
SponsorThe University of Texas Medical Branch, Galveston
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer, Breast Cancer Female, Muscle Weakness
About this study
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.
Interventions
- 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.
Primary outcomes
- Change in strength in breast cancer survivors (baseline and 12 weeks)
- Change in physical functional capacity in breast cancer survivors (baseline and 12 weeks)
Eligibility information
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
Study locations
- The University of Texas Medical Branch, Galveston, Galveston, Texas 77555 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.