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NCT Number: NCT06395506

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary objective is to determine the effects of creatine in modulating strength and physical function in cancer survivors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine

Dietary Supplement

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 outcomes

  1. Change in strength in breast cancer survivors

    Time frame: baseline and 12 weeks

    Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.

  2. Change in physical functional capacity in breast cancer survivors

    Time frame: baseline and 12 weeks

    Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.

Secondary outcomes

  1. Change intramuscular storage of creatine

    Time frame: baseline and 12 weeks

    Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.

  2. Change in body composition in cancer survivors

    Time frame: baseline and 12 weeks

    Determine the change in body composition in breast cancer survivors by pre and post measurements of bone mass as well as lean vs fat mass via a DEXA scan.

  3. Change in the return of strength for breast cancer survivors with creatine + exercise

    Time frame: 12 weeks

    Breast cancer survivors who complete 12-weeks of exercise with creatine supplementation group who regained strength and physical function to that of women of similar age who never had cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Thibodeaux, RN,BSN

CONTACT

[email protected]

4094741756

Rebecca Geck, MPH,APRN,CPT

CONTACT

[email protected]

4092660496

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • ThriveWell Cancer Foundation

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 2, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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