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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20190610H | Other Identifier | UT Health Science Center San Antonio IRB |
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| Name | Class |
|---|---|
| ThriveWell Cancer Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | From baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12 weeks |
| Change in muscle cross sectional area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darpan I Patel, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363152 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018908 | Muscle Weakness |
| D009133 | Muscular Atrophy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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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.
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Magnetic resonance imaging will be used to capture the mid-thigh cross section. |
| From baseline to 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D001519 | Behavior |
| D000602 |
| Amino Acids, Peptides, and Proteins |