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New treatment option for Breast Cancer
Official title THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
ClinicalTrials.gov ID: NCT06395506
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- (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
You likely can't join if
- (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+
See the full eligibility 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.
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.