THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
Recruiting
N/AInterventional Study
Breast CancerBreast Cancer FemaleMuscle Weakness
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
60 (estimated)
Sponsor
The University of Texas Medical Branch, Galveston · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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 abl…
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
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