RightFit
RecruitingNot applicable

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether creatine supplements help breast cancer survivors gain strength and endurance faster with exercise and change their body fat and muscle levels. It compares survivors who finished chemotherapy with healthy women of the same age who have never had cancer. Both groups are ages 18–75.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Be 18–75 years old and willing to agree to join the study.
  • Breast cancer group: Have had breast cancer that needed chemotherapy, and finished chemotherapy within the past 6 months.
  • Breast cancer group: Be willing to join 3 online exercise sessions each week and able to take medicine by mouth.
  • Breast cancer group: Have a creatinine blood level no more than 1.5 times the upper normal limit, or an eGFR of at least 30. These tests check how well your kidneys work.
  • Healthy group: Have never been diagnosed with cancer.

Who can't join

  • Both groups: Have a condition that limits exercise or makes it unsafe; moderate to severe heart disease; or lung disease causing shortness of breath after climbing one flight of stairs or less, or unusual breathing sounds.
  • Both groups: Have blood pressure above 160/95 or swelling rated above 2+ that leaves a dent when pressed.
  • Both groups: Have used tobacco within 6 months, use anabolic steroids, or currently take creatine supplements.
  • Both groups: Have a creatinine blood level above 1.5 times the upper normal limit or an eGFR below 30. These tests check kidney function.
  • Both groups: Be pregnant. Breast cancer group: Also excluded if planning pregnancy during the study. Healthy group: Also excluded if taking prescribed medicine to prepare for pregnancy.
  • Breast cancer group: Be receiving chemotherapy, or have used corticosteroid medicines or appetite boosters within 1 month or expect to use them. Short-term corticosteroids during chemotherapy are allowed. Healthy group: Have any past cancer diagnosis, or have used corticosteroids, appetite boosters, or appetite reducers within 1 month.
  • Healthy group: Have bipolar disorder, a screening score suggesting bipolar disorder, a brain or nerve disorder, or uncontrolled diabetes with an A1c of 6.5% or higher. A1c measures average blood sugar.
  • Both groups: Lack access to a smartphone or the internet.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

TX