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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 85417 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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It is estimated that one-third of the more than 7 million deaths from cancer worldwide are attributable to potentially modifiable risk factors, with 374,000 deaths preventable through diet modification alone. Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also suggests that muscadine grape products may decrease systemic inflammation. This study builds upon promising preclinical and clinical evidence to determine if the addition muscadine grape extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate cancer.
Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months.
Secondary Objectives
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
GROUP II (PLACEBO): Participants begin Androgen deprivation therapy prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 72 hours and then for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGE group | Experimental | Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
|
| Placebo group | Placebo Comparator | Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGE | Drug | The patients will take 4 capsules by mouth BID (twice daily). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fatigue | The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: <50 normal; 50-59 mild; 60-69 moderate; ≥70 severe. 50 indicates the population mean with a standard deviation of 10 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life: PROMIS | General Quality of Life will be measured using the Patient Reported Outcomes Measurement Information System© (PROMIS©) Global Health Short Form (SF), a 10-item instrument representing multiple domains. Items assess self-reported measures of general aspects of physical, mental and social health in adults. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better general health than the general population. |
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Inclusion Criteria:
White blood cell count greater than or equal to 3,500/mcL (or 3.5 (x103)) Platelet count greater than or equal to 75,000/mcL (or 75 (x103)) Hemoglobin greater than or equal to >9 g/dL Total bilirubin less than or equal to 2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal Creatinine less than or equal to 2.5 X institutional upper limit of normal
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WG Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States | ||
| Wake Forest Baptist Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | MGE Group | Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. MGE: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
| FG001 | Placebo Group | Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo. Placebo: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MGE Group | Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. MGE: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Changes in Fatigue | The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: <50 normal; 50-59 mild; 60-69 moderate; ≥70 severe. 50 indicates the population mean with a standard deviation of 10 | Posted | Mean | Standard Error | T-score | 6 months |
|
1 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 | MGE Group | Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. MGE: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 3367135045 | mvelasqu@wakehealth.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 | Apr 2, 2025 | Feb 18, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2025 | Sep 24, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a double-blind study. Only the lead-site investigational pharmacy team and the statistician will unblinded. The blind will be maintained until the study is complete.
| Placebo |
| Other |
The patients will take 4 capsules by mouth BID (twice daily). |
|
| ADT | Other | Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
|
| Baseline and 6 months |
| Changes in Quality of Life: HFRDIS | Quality of life will be assessed by the Hot Flash Related Daily Interference Scale (HFRDIS). HFRDIS is a 10-item scale that assesses the degree to which hot flashes interfere with a variety of daily activities and quality of life. Interference is rated on an 11-point scale (0=not interfere; 10=completely interfere). Higher scores indicate more interference. | Baseline and 6 months |
| Changes in Sleep Disturbance | Sleep disturbance will be measured using the PROMIS Sleep Disturbance (SD) SF 8a. The PROMIS-SD items assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question has five response options ranging in value from one to five. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted to a standardized T-score. Higher scores indicate more sleep disturbance. | Baseline and 6 months |
| Changes in Cognitive Abilities | Cognitive abilities will be measured using the PROMIS Cognitive Abilities SF 4a, which assesses patient-perceived functional abilities related to mental acuity, concentration, and memory. Raw scores are converted to a standardized T-score; final scores are represented by the T-score. Higher scored indicate more cognitive ability. | Baseline and 6 months |
| Changes in Self-reported Physical Function | Self-reported physical function will be measured using the PROMIS Physical Function 10a SF, which is designed to assess self-reported capability rather than actual performance of physical activities. The form consists of 10 items. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better physical function general health than the general population. | Baseline and 6 months |
| Changes in Physical Performance | Physical performance will be objectively assessed using the Short Physical Performance Battery (SPPB). Each performance measure is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level), with total sum score range from 0-12. Lower score on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer. | Baseline and 6 months |
| Changes in Sub-maximal Exercise | Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness. | baseline and 6 month |
| Changes in Body Composition | Whole body lean mass, fat mass, and bone mass will be measured by duel energy X-ray absorptiometry (DXA). BMI will be calculated from height and weight. | Baseline and 6 months |
| Changes in Prostate-specific Antigen (PSA) Progression | PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo. | baseline, 6, and 12 months |
| Progression-free Survival | Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death. | up to 12 months |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG001 | Placebo Group | Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo. Placebo: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Group | Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo. Placebo: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. |
|
|
|
| Secondary | Changes in Quality of Life: PROMIS | General Quality of Life will be measured using the Patient Reported Outcomes Measurement Information System© (PROMIS©) Global Health Short Form (SF), a 10-item instrument representing multiple domains. Items assess self-reported measures of general aspects of physical, mental and social health in adults. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better general health than the general population. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Quality of Life: HFRDIS | Quality of life will be assessed by the Hot Flash Related Daily Interference Scale (HFRDIS). HFRDIS is a 10-item scale that assesses the degree to which hot flashes interfere with a variety of daily activities and quality of life. Interference is rated on an 11-point scale (0=not interfere; 10=completely interfere). Higher scores indicate more interference. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Sleep Disturbance | Sleep disturbance will be measured using the PROMIS Sleep Disturbance (SD) SF 8a. The PROMIS-SD items assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question has five response options ranging in value from one to five. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted to a standardized T-score. Higher scores indicate more sleep disturbance. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Cognitive Abilities | Cognitive abilities will be measured using the PROMIS Cognitive Abilities SF 4a, which assesses patient-perceived functional abilities related to mental acuity, concentration, and memory. Raw scores are converted to a standardized T-score; final scores are represented by the T-score. Higher scored indicate more cognitive ability. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Self-reported Physical Function | Self-reported physical function will be measured using the PROMIS Physical Function 10a SF, which is designed to assess self-reported capability rather than actual performance of physical activities. The form consists of 10 items. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better physical function general health than the general population. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Physical Performance | Physical performance will be objectively assessed using the Short Physical Performance Battery (SPPB). Each performance measure is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level), with total sum score range from 0-12. Lower score on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Sub-maximal Exercise | Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness. | Not Posted | Aug 2026 | baseline and 6 month | Participants |
| Secondary | Changes in Body Composition | Whole body lean mass, fat mass, and bone mass will be measured by duel energy X-ray absorptiometry (DXA). BMI will be calculated from height and weight. | Not Posted | Aug 2026 | Baseline and 6 months | Participants |
| Secondary | Changes in Prostate-specific Antigen (PSA) Progression | PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo. | Not Posted | Aug 2026 | baseline, 6, and 12 months | Participants |
| Secondary | Progression-free Survival | Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death. | Not Posted | Aug 2026 | up to 12 months | Participants |
| 1 |
| 53 |
| 6 |
| 53 |
| 43 |
| 53 |
| EG001 | Placebo Group | Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo. Placebo: The patients will take 4 capsules by mouth BID (twice daily). ADT: Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE. | 0 | 53 | 8 | 53 | 43 | 53 |
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |