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Lay Description

The purpose of this study is to test whether creatine supplements can accelerate improvements in strength and endurance associated with exercise in breast cancer survivors recently completing chemotherapy.

Category

  • Cancers and Other Neoplasms
  • Rehabilitation
  • Womens Health
  • Muscle, Bone and Cartilage
  • Exercise
  • Breast - Female
  • Breast Neoplasm
  • Cancer Survivors
IRB Number
20190610HU
NCT Number
NCT04207359
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18-75 years of age
  • Recent (within 6 months) completion of chemotherapy
  • Willing to attend 3 exercise sessions per week via Zoom
  • 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

  • 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
  • Currently undergoing infusion chemotherapy.
  • 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 get pregnant during the study
  • Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, 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

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Amber Gallegos
(210) 606-2437
gallegosa4@uthscsa.edu

Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Regulatory Point of Contact
Diana Jarbeau-may
(210) 617-5390
jarbeaumay@uthscsa.edu

Regulatory Point of Contact
Crisann Moon
(210) 288-0488
moonc1@uthscsa.edu

Regulatory Point of Contact
Darpan Patel
(210) 567-0362
pateld7@uthscsa.edu

Local Recruitment Point of Contact
Amber Gallegos
(210) 606-2437
gallegosa4@uthscsa.edu

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Crisann Moon
(210) 288-0488
moonc1@uthscsa.edu

Overall Recruitment Point of Contact
Angela Gonzalez

gonzaleza46@uthscsa.edu

Principal Investigator
Darpan Patel