THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement 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 measures

• 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]

Secondary outcome measures (3)

• Change intramuscular storage of creatine [Time frame: baseline and 12 weeks]
• Change in body composition in cancer survivors [Time frame: baseline and 12 weeks]
• Change in the return of strength for breast cancer survivors with creatine + exercise [Time frame: 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• The University of Texas Medical Branch, Galveston — Galveston

Publications

• Sonawane MA, Lee AK, Gaikwad S, Almeida GJ, Darby NT, Calderon T, Ramirez AG, Hughes DC, Patel DI. Therapeutic Yoga Enhances Neuroplasticity and Metabolic Regulation Through Elevated Plasma Brain-Derived Neurotrophic Factor (BDNF) and Ghrelin in a Heterogeneous Cancer Survivor Population. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251385573. doi: 10.1177/15347354251385573. Epub 2025 Oct 23. PMID 41128015

Identifiers

NCT: NCT06395506 · 23-0215

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗