Recruiting

Exercise & Creatine

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06395506

Conditions

Breast Cancer

Breast Cancer Female

Muscle Weakness

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Creatine

Study Details

Brief 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.

Conditions

Breast Cancer

Breast Cancer Female

Muscle Weakness

Study ID

NCT06395506

Start date

Oct 29, 2024

Status verified date

Dec, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Age-Matched Control Group

Women who have never been diagnosed with cancer.

experimental: Creatine Supplement Group

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. Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

no intervention: Non-Creatine Supplement Group

Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a Fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Interventions

Creatine

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.

Primary outcome measure

  • Change in strength in breast cancer survivors [ Time Frame: baseline and 12 weeks ]
  • Change in physical functional capacity in breast cancer survivors [ Time Frame: baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

Lisa Thibodeaux, RN,BSN

4094741756lbthibod@utmb.edu

Rebecca Geck, MPH,APRN,CPT

4092660496raschaef@utmb.edu

Locations

The University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Lisa Thibodeaux, RN,BSN

409-474-1756lbthibod@utmb.edu

Rebecca Geck, MPH,APRN,CPT

4092660496raschaef@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Breast Cancer
  • Breast Cancer Female
  • Exercise
  • Creatine Supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-12-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.