Breast CancerTHRIVENCT06395506
THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
A study testing Creatine in people with Breast Cancer and Breast Cancer Female, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Muscle Weakness
- What is being tested?
- Creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
- Age 18-75 years of age
- Have never been diagnosed with cancer
- Willing to provide consent to participate in this study
Who cannot join
- 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
Show all 28Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Lisa Thibodeaux, RN,BSN, 409-474-1756, lbthibod@utmb.edu
Rebecca Geck, MPH,APRN,CPT, 4092660496, raschaef@utmb.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Breast Cancer Female, Muscle Weakness
- Being tested
- Creatine
- Keywords
- Breast Cancer, Breast Cancer Female, Exercise, Creatine Supplement
- Medical subject headings
- Breast Neoplasms, Muscle Weakness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Age-Matched Control Group | No intervention | Women who have never been diagnosed with cancer. |
| Creatine Supplement Group | Experimental | 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. Receives: Dietary Supplement: Creatine |
| Non-Creatine Supplement Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and 12 weeks
Secondary outcomes (3)
Change intramuscular storage of creatine
Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start29 Oct 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- ThriveWell Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Darpan Patel, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395506
- Sponsor's protocol ID
- 23-0215
- Acronym
- THRIVE
- Status last verified
- Dec 2025
- First submitted
- 19 Apr 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41128015
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06395506
- Acronym / sponsor ID
- THRIVE / 23-0215
- Conditions
- Breast Cancer, Breast Cancer Female, Muscle Weakness
- Keywords
- Breast Cancer, Breast Cancer Female, Exercise, Creatine Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- ThriveWell Cancer Foundation
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.
| Arm | Type | Receives |
|---|---|---|
| Age-Matched Control Group | No intervention | –Women who have never been diagnosed with cancer. |
| Creatine Supplement Group | Experimental | Dietary Supplement: CreatineThose 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. |
| Non-Creatine Supplement Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (28 listed)
- 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+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineThose 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. | Dietary supplement | Creatine Supplement Group |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 41128015Sonawane 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darpan Patel, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Breast Cancer and Breast Cancer Female, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Thibodeaux, RN,BSN (4094741756, lbthibod@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in strength in breast cancer survivors (time frame: baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.