Evaluating creatine supplementation for breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the impact of creatine supplementation on strength, endurance, and body composition in breast cancer survivors who have recently completed chemotherapy. Participants will engage in virtual exercise sessions while their responses to creatine will be compared to healthy women of similar age. The primary focus is on how creatine can enhance physical function and recovery in this population.

Why it matters

Who can join: the full rules

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's running

• The University of Texas Medical Branch, Galveston
  Galveston, Texas, United States Recruiting

Study contacts

• Principal investigator: Darpan Patel, PhD — University of Texas
• Study coordinator: Lisa Thibodeaux, RN,BSN
• Email: lbthibod@utmb.edu
• Phone: 4094741756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.