Evaluating creatine supplementation for breast cancer survivors
An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors
This study is testing if taking creatine can help breast cancer survivors improve their strength, endurance, and body composition after finishing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06395506 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18-75 who have completed chemotherapy within the last six months.
Not a fit: Patients currently undergoing chemotherapy or with significant physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the physical recovery and quality of life for breast cancer survivors.
How similar studies have performed: While the specific combination of creatine supplementation and exercise in breast cancer survivors is novel, similar studies have shown positive outcomes with exercise interventions in cancer recovery.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Galveston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.