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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

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Male Urogenital Diseases

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Herbal and Botanical

Androgens

Grape

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.

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.

The patients will take 4 capsules by mouth BID (twice daily).

Placebo

Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.

Katherine Pleasant

Study Nurse

Michael Goodman, MD

Katherine Pleaseant

Heidi Klepin, MD

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

* To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months.
* To compare quality of life in men in the MGE group compared to the placebo group.
* To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group.
* To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group.
* To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group.

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.

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.

Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

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.

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.

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.

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.

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.

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.

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.

Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.

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.

PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo.

Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy	NCT03496805	Recurrent Prost...	MGE Placebo ADT	18 Years -	Wake Forest University Health Sciences
Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy	NCT03496805	Recurrent Prost...	MGE Placebo ADT	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for mge

Every month we try and update this database with for mge cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mge

Every month we try and update this database with for mge cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mge cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.