Breast CancerNCT04207359
Effects of Creatine Supplementation in Breast Cancer Survivors
A study testing Creatine in people with Breast Cancer and Chemotherapy Effect, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect, Muscle Weakness
- What is being tested?
- Creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years of age
- Recent (within 6 months) completion of chemotherapy
- Willing to attend 3 virtual 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.
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
- Currently undergoing chemotherapy
Show all 11Show 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 get pregnant during the study
- Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors
The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.
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 hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.
- Conditions
- Breast Cancer, Chemotherapy Effect, Muscle Weakness, Muscle Loss, Exercise
- Being tested
- Creatine
- Keywords
- Special Populations, Exercise Oncology, Creatine Supplementation, Magnetic Resonance Spectroscopy
- Medical subject headings
- Breast Neoplasms, Muscle Weakness, Muscular Atrophy, 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 |
|---|---|---|
| Creatine Supplement Group | Experimental | 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 |
| Exercise Only Control Group | No intervention | Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength in breast cancer survivors
Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.
Measured: From baseline to 12 weeks
Change in functional capacity in breast cancer survivors
Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).
Measured: From baseline to 12 weeks
Secondary outcomes (2)
Change in intramuscular creatine and altering energy storage.
Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.
Measured: From baseline to 12 weeks
Change in muscle cross sectional area
Magnetic resonance imaging will be used to capture the mid-thigh cross section.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start30 Sep 2020
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ThriveWell Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Darpan I Patel, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207359
- Sponsor's protocol ID
- CTMS# 19-0028
- Other IDs
- HSC20190610H
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel DI, Gonzalez A, Moon C, Serra M, Bridges PB, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N. Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study). JMIR Res Protoc. 2022 Apr 1;11(4):e26827. doi: 10.2196/26827.
PubMed 35363152
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04207359
- Acronym / sponsor ID
- CTMS# 19-0028
- Conditions
- Breast Cancer, Chemotherapy Effect, Muscle Weakness, Muscle Loss, Exercise
- Keywords
- Special Populations, Exercise Oncology, Creatine Supplementation, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- ThriveWell Cancer Foundation
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 20 Dec 2019 (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 purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.
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 hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. 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 |
|---|---|---|
| Creatine Supplement Group | Experimental | Dietary Supplement: CreatineParticipants 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. |
| Exercise Only Control Group | No intervention | –Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years of age
- Recent (within 6 months) completion of chemotherapy
- Willing to attend 3 virtual exercise sessions per week
- Able to take oral medications
- Participant is willing and able to provide consent to participating in the study
Key exclusion criteria (11 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
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: From baseline to 12 weeks
Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.
Change in functional capacity in breast cancer survivors
Time frame: From baseline to 12 weeks
Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).
2 secondary outcomes
Change in intramuscular creatine and altering energy storage.
Time frame: From baseline to 12 weeks
Change in muscle cross sectional area
Time frame: From baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 35363152Patel DI, Gonzalez A, Moon C, Serra M, Bridges PB, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N. Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study). JMIR Res Protoc. 2022 Apr 1;11(4):e26827. doi: 10.2196/26827.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Darpan I Patel, PhD principal investigator
The University of Texas Health Science Center at San Antonio
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 Chemotherapy Effect, run by The University of Texas Health Science Center at San Antonio 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 25 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in strength in breast cancer survivors (time frame: From baseline to 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 NCT04207359, 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 25 Jul 2023.