THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors
The University of Texas Medical Branch, Galveston
60 participants
Oct 29, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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.
- Age 18-75 years of age
- Have never been diagnosed with cancer
- Willing to provide consent to participate in this study
Exclusion Criteria28
- 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
- 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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06395506