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The study has been suspended by the IRB pending review of a study-related issue
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This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) | Experimental | 800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily |
|
| Microcrystalline cellulose (MCC) | Placebo Comparator | 800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) | Drug | 800mg Epigallocatechin-3-Gallate (EGCG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks. | We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)
Have uncontrolled or unmanaged liver disease.
Consume more than 6 cups of green tea per day.
Have known allergies to caffeine.
Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
Be diagnosed with dementia.
Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14627 | United States |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| C109691 | microcrystalline cellulose |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
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| Microcrystalline cellulose (MCC) | Drug | 800mg microcrystalline cellulose (MCC) |
|
|
| Ascorbic Acid (Vitamin C) | Dietary Supplement | 250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks |
|
|
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |