THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
Recruiting · NCT06395506 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Medical Branch, Galveston
View the official record on ClinicalTrials.gov →Interventions studied
Creatine
What this trial 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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- The University of Texas Medical Branch, Galveston - Galveston, Texas, United States