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| Name | Class |
|---|---|
| ThriveWell Cancer Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| 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 | 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 |
| 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 |
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Inclusion criteria (Breast Cancer Group)
Exclusion criteria (Breast Cancer Group)
Inclusion Criteria (Healthy Age-matched Control Group)
Exclusion Criteria (Healthy Age-matched Control Group)
hormonal therapy for IVF)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Thibodeaux, RN,BSN | Contact | 4094741756 | lbthibod@utmb.edu | |
| Rebecca Geck, MPH,APRN,CPT | Contact | 4092660496 | raschaef@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Darpan Patel, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch, Galveston | Recruiting | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41128015 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018908 | Muscle Weakness |
| 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. 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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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 |
| 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 |
| D001519 | Behavior |
| D000602 |
| Amino Acids, Peptides, and Proteins |