THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation (THRIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Muscle Weakness; Breast Cancer Female
• Intervention / Treatment: Dietary supplement: Creatine

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Thibodeaux, RN,BSN; Phone Number: 4094741756; Email: lbthibod@utmb.edu
• Study Contact Backup: Name: Rebecca Geck, MPH,APRN,CPT; Phone Number: 4092660496; Email: raschaef@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • The University of Texas Medical Branch, Galveston
      • Contact: Rebecca Geck, MPH,APRN,CPT; Phone Number: 4092660496; Email: raschaef@utmb.edu
      • Contact: Lisa Thibodeaux, RN,BSN; Phone Number: 409-474-1756; Email: lbthibod@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in strength in breast cancer survivors	Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.	baseline and 12 weeks
Change in physical functional capacity in breast cancer survivors	Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change intramuscular storage of creatine	Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.	baseline and 12 weeks
Change in body composition in cancer survivors	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.	baseline and 12 weeks
Change in the return of strength for breast cancer survivors with creatine + exercise	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.	12 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: ThriveWell Cancer Foundation
• Investigators: Principal Investigator: Darpan Patel, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer; Breast Cancer Female; Creatine Supplement
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Signs and Symptoms; Breast Neoplasms; Muscle Weakness; Motor Activity; Amino Acids, Peptides, and Proteins; Organic Chemicals; Amino Acids; Guanidines; Amidines; Creatine
• Other Study ID Numbers: 23-0215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No