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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01710 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01815 | Other Identifier | Wake Forest University Health Sciences | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and the best dose of muscadine grape skin extract (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an extract of the skin of muscadine grape that has shown anti-cancer activity in laboratory studies and may be able to fight or kill malignant cells.
PRIMARY OBJECTIVES:
I. To determine the safety and maximum tolerated dose (MTD) of MGE (muscadine grape skin extract) after 4 weeks of administration for patients with metastatic cancer.
Secondary Objectives:
I. To monitor adverse events/toxicity every 4 weeks while on treatment. II. To evaluate change in phenolic levels (total and component, blood and urine) from baseline to 4 and 8 weeks.
III. To evaluate change in serum cytokines and growth factors from baseline to 4 and 8 weeks on MGE.
IV. To observe the response rate of MGE in patients with metastatic cancer. V. To assess overall and progression-free survival in patients with metastatic cancer receiving MGE.
VI. To assess global quality of life (Functional Assessment of Cancer Therapy-General [FACT-G] and fatigue (Patient Reported Outcomes Measurement Information System [PROMIS]-fatigue Short Form [SF]) in cancer patients taking MGE.
VII. To assess adherence to MGE treatment.
OUTLINE: This is a dose-escalation study.
Patients receive muscadine grape skin extract orally (PO) twice daily (BID). Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (muscadine grape skin extract) 1 pill 2 times a day | Experimental | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. |
|
| Arm 2 (muscadine grape skin extract) 2 pills 2 times a day | Experimental | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. |
|
| Arm 3 (muscadine grape skin extract) 3 pills 2 times a day | Experimental | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. |
|
| Arm 4 (muscadine grape skin extract) 4 pills 2 times a day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Diagnostic Test | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicity | Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in >= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period | Pill count will be calculated from counting the number of pills returned as well as by summarizing the patient's pill diary. The percent of pills taken will be summarized by dose level using the median and 95% confidence interval. Investigators will summarize the percent of pills taken at the end of every 4 week period i using the formula: Percent of pills taken)i = (Dose Level ×7 ×4)i minus Pill Count divided by Dose Level ×7 ×4)i |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33867481 | Derived | Bitting RL, Tooze JA, Isom S, Petty WJ, Grant SC, Desnoyers RJ, Thomas A, Thomas CY, Alistar AT, Golden SL, Pleasant K, Chappell MC, Tallant EA, Gallagher PE, Klepin HD. Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer. Am J Clin Oncol. 2021 Jun 1;44(6):239-246. doi: 10.1097/COC.0000000000000814. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 5, 2018 |
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| Experimental |
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. |
|
| Arm 5 muscadine grape skin extract) 5 pills 2 times a day | Experimental | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. |
|
| Muscadine Grape Skin Extract | Drug | Given PO |
|
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| Quality-of-Life Assessment | Procedure | Ancillary studies |
|
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| Up to 1 year |
| Best Response | Best response will be characterized using a frequency table. Evaluation of new or enlarging effusions to differentiate between Progressive Disease and Response/Stable Disease. Measurements will be obtained from usual care imaging and assessed by the principal investigators in confirmation with the physician of record. Clinical lesions will only be considered measurable when they are superficial and ≥10 mm in diameter as assessed using calipers. For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended. | At the end of treatment, up to 1 year |
| Change in Total Phenolic Levels in Blood | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Change in Total Phenolic Levels in Urine | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G | A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. Score scales from 0 (not at all) to 4 (very much). Sum of scores range 0-28 for social, functional and physical well being and 0-24 for emotional well being and multiplied by 6. All four scores are totaled with a score range of 0-108. A mean of the combined group scores will be used. A higher score indicates a higher worse outcome of the illness on the participant. | Baseline to up to 1 year |
| Change in Systemic Cytokine Levels | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0 | AEs/toxicity will be assessed at weeks 4, 8 and every 4 weeks thereafter if patients remain on treatment. Any expected toxicities, any laboratory based toxicities, and any grade 3 or higher gastrointestinal toxicities, and any grade 4 or higher toxicities will be summarized using frequency tables overall and by week. | Up to 1 year |
| Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease) | Response will be characterized using a frequency table. | At 8 weeks |
| Overall Survival (OS) | OS will summarized using the Kaplan-Meier method. Median survival rates and associated 95% confidence intervals will be calculated. | Up to 4 years |
| Progression-free Survival (PFS) | PFS will summarized using the Kaplan-Meier method. | Up to 4 years |
| Change in Component Phenolic Levels in Urine | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Change in Component Phenolic Levels in Blood | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF | A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. A 6-item questionnaire with T-score responses ranging from a minimum of 33.4 to a maximum of 76.8. Higher scores equals more of the concept being measured. | Baseline to up to 1 year |
| Change in Systemic Cytokine Levels (Log IL-8) | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| Change in Systemic Cytokine Levels (Log VEGF) | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Baseline to up to 8 weeks |
| FG001 | Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| FG002 | Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| FG003 | Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| FG004 | Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG001 | Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG002 | Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG003 | Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG004 | Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Dose-Limiting Toxicity | Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in >= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events. | As pre-specified in the protocol, data collection and analysis for all arms will be combined. MTD was not determined, as there was not a dose level with ≥2 dose limiting toxicities (DLT). One DLT at dose level 2 and therefore 3 additional participants were enrolled. No subsequent DLTs and the study was stopped at dose level 5, per protocol. | Posted | Count of Participants | Participants | 29 days |
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| Secondary | Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period | Pill count will be calculated from counting the number of pills returned as well as by summarizing the patient's pill diary. The percent of pills taken will be summarized by dose level using the median and 95% confidence interval. Investigators will summarize the percent of pills taken at the end of every 4 week period i using the formula: Percent of pills taken)i = (Dose Level ×7 ×4)i minus Pill Count divided by Dose Level ×7 ×4)i | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for Adherence to EMG treatment. | Posted | Median | 95% Confidence Interval | percentage of pills | Up to 1 year |
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| Secondary | Best Response | Best response will be characterized using a frequency table. Evaluation of new or enlarging effusions to differentiate between Progressive Disease and Response/Stable Disease. Measurements will be obtained from usual care imaging and assessed by the principal investigators in confirmation with the physician of record. Clinical lesions will only be considered measurable when they are superficial and ≥10 mm in diameter as assessed using calipers. For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for Best Response | Posted | Count of Participants | Participants | At the end of treatment, up to 1 year |
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| Secondary | Change in Total Phenolic Levels in Blood | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for change in total phenolic levels in blood. | Posted | Mean | Standard Error | ug/ml | Baseline to up to 8 weeks |
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| Secondary | Change in Total Phenolic Levels in Urine | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Arms were combined for cytokine and phenolic analyses as pre-specified per protocol | Posted | Mean | Standard Error | ug/ml | Baseline to up to 8 weeks |
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| Secondary | Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G | A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. Score scales from 0 (not at all) to 4 (very much). Sum of scores range 0-28 for social, functional and physical well being and 0-24 for emotional well being and multiplied by 6. All four scores are totaled with a score range of 0-108. A mean of the combined group scores will be used. A higher score indicates a higher worse outcome of the illness on the participant. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for change in quality of life. All participants did not complete intervention for outcome measures are various time points (i.e., week 4 and week 8) | Posted | Mean | Standard Error | score on a scale | Baseline to up to 1 year |
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| Secondary | Change in Systemic Cytokine Levels | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Arms were combined for cytokine and phenolic analyses as pre-specified per protocol | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline to up to 8 weeks |
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| Secondary | Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0 | AEs/toxicity will be assessed at weeks 4, 8 and every 4 weeks thereafter if patients remain on treatment. Any expected toxicities, any laboratory based toxicities, and any grade 3 or higher gastrointestinal toxicities, and any grade 4 or higher toxicities will be summarized using frequency tables overall and by week. | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease) | Response will be characterized using a frequency table. | As pre-specified in the protocol, data will be collected and analyzed for all arms combined. At 8 weeks, only 16 patients were evaluable. | Posted | Count of Participants | Participants | At 8 weeks |
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| Secondary | Overall Survival (OS) | OS will summarized using the Kaplan-Meier method. Median survival rates and associated 95% confidence intervals will be calculated. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for overall survival. | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
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| Secondary | Progression-free Survival (PFS) | PFS will summarized using the Kaplan-Meier method. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for progression free survival. | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
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| Secondary | Change in Component Phenolic Levels in Urine | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Posted | Mean | Standard Error | ug/ml | Baseline to up to 8 weeks |
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| Secondary | Change in Component Phenolic Levels in Blood | A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Outcome measure was not measured | Posted | Baseline to up to 8 weeks |
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| Secondary | Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF | A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. A 6-item questionnaire with T-score responses ranging from a minimum of 33.4 to a maximum of 76.8. Higher scores equals more of the concept being measured. | As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for change in quality of life. Not all participants completed intervention at the week 4 and week 8 time frames to be analyzed | Posted | Mean | Standard Error | T-score | Baseline to up to 1 year |
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| Secondary | Change in Systemic Cytokine Levels (Log IL-8) | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Arms were combined for cytokine and phenolic analyses as pre-specified per protocol | Posted | Least Squares Mean | Standard Error | log pg/mL | Baseline to up to 8 weeks |
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| Secondary | Change in Systemic Cytokine Levels (Log VEGF) | A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8. | Arms were combined for cytokine and phenolic analyses as pre-specified per protocol | Posted | Least Squares Mean | Standard Error | log pg/mL | Baseline to up to 8 weeks |
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One year
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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 | Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies | 1 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO | 0 | 6 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death, not otherwise specified | General disorders | CTCAE (4.0) | Systematic Assessment | Only 21 participants were evaluable for adverse events during this reporting cycle. Additional adverse events will be included at end of study. |
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| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Only 21 participants were evaluable for adverse events during this reporting cycle. Additional adverse events will be included at end of study. |
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| Eye disorders | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema, face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema, limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions, other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue, other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delusions | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Nurse | Wake Forest University Health Sciences | 336-713-7748 | saverill@wakehealth.edu |
| Apr 2, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2017 | Jun 1, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
|
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|
|
| OG002 | Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| OG003 | Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
| OG004 | Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day | Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies |
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| Participants |
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