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The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day |
|
| Usual Care Group | No Intervention | No study pills |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) | Drug | 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility: Rates of Consent | Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study. | Baseline |
| Recruitment Feasibility: Rates of Randomization | Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms. | Baseline |
| The Proportion of Participants That Completed the Study | To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit. | 12 week |
| The Proportion of Participants That Were Adherent to the Intervention | To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking >70% of study drug). | 12 week |
| Safety of the EGCG Intervention | Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria: Study subjects must not:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14627 | United States |
Sixty four (64) potentially eligible participants were approached and 24 participants were consented. Of the 24 consented subjects: 5 screen failed (participant was consented but didn't fully meet eligibility criteria e.g. meet frailty cut off or liver toxicity screen); 4 screen withdrew (participant was consented but withdrew from the study before the baseline visit for randomization), and 1 was lost to follow up. Fourteen (14) participants were randomized to the treatment groups.
Patients were recruited from clinical sites within Wilmot Cancer Institute between April 2021 and March 2023. Eligible patients were aged 65 or older, diagnosed with Stage I-III solid cancer, completed curative intent treatment 10 years or less before being screened, and had a Fried's Frailty Score (FFS ≥ 2); assessed by measuring grip strength, weight loss, physical activity, fatigue, and a 4-meter walk test. The first participant was consented on April 28, 2021, and randomized on May 6, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks |
| FG001 | Usual Care Group | No study pills. Followed Usual Care procedures for a survivor of cancer according to oncology care teams' directions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 14 subjects whose baseline measurements were received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks |
| BG001 | Usual Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility: Rates of Consent | Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study. | Since this outcome measure looks at the number of participants approached versus consented, the number of participants analyzed was the 64 approached instead of the 14 that were randomized. | Posted | Number | proportion of participants | Baseline |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation - Grade 1 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nikesha Gilmore, Assistant Professor | University of Rochester Medical Center | 1-585-275-1275 | nikesha_gilmore@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 | Aug 6, 2024 | Prot_SAP_000.pdf |
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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 |
| 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 gallate (EGCG) + 250mg Ascorbic Acid
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|
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Cancer Stage | Cancer stage was reviewed from the patient's medical records and confirmed with their provider to ensure eligibility. Stage 0: abnormal cells are present and have not spread to nearby tissue. Stage 1: the cancer is small and contained within the organ it started in. Stage 2: the cancer has grown and possibly spread to nearby lymph nodes. Stage 3: the cancer has grown more and has spread to surrounding tissues including nearby lymph nodes. Stage 4: the cancer had spread to distant parts of the body. | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Cancer Treatment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Recruitment Feasibility: Rates of Randomization | Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms. | Since this outcome measure looks at the number of participants consented versus randomized, the number of participants analyzed was the 24 consented instead of the 14 that were randomized. | Posted | Number | proportion of participants | Baseline |
|
|
|
| Primary | The Proportion of Participants That Completed the Study | To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit. | Posted | Number | proportion of participants | 12 week |
|
|
|
| Primary | The Proportion of Participants That Were Adherent to the Intervention | To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking >70% of study drug). | Posted | Number | proportion of participants | 12 week |
|
|
|
| Primary | Safety of the EGCG Intervention | Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported. | Posted | Number | Participants | 12 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Usual Care Group | No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions. | 0 | 7 | 0 | 7 | 3 | 7 |
| Diarrhea - Grade 1 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Indigestion/Dyspesia - Grade 1 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea - Grade 1 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia - Grade 1 | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Gas/Flatulence - Grade 1 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Gas/Flatulence - Grade 2 | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| Constipation-Grade 1 |
|
| Diarrhea-Grade 1 |
|
| Indigestion/Dyspepsia-Grade 1 |
|
| Nausea-Grade 1 |
|
| Fatigue-Grade 1 |
|
| Insomnia-Grade 1 |
|