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

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ClinicalTrials.gov Identifier: NCT03496805
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Cancer Drug: MGE Other: Placebo Other: ADT Phase 2

Detailed Description:
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. The muscadine grape contains a high concentration of anthocyanin 3,5-diglucosides, ellagic acid, ellagic acid precursors, gallic acid, flavan-3-ols and flavonols. Several preclinical studies with muscadine grape products have revealed anti-tumor activity, including inhibition of tumor cell growth and induction of apoptosis. By reducing levels of circulating inflammatory markers such as CRP and IL-6, muscadine grape products may improve cancer outcomes by decreasing symptom burden, particularly fatigue. Despite reports indicating potential anti-tumor activity, there are limited clinical studies on the efficacy of muscadine grape products in the prevention or treatment of cancer or cancer-related side effects, representing an opportunity for novel investigation. The primary goal will be to determine whether treatment with MGE can improve measures of fatigue in men with biochemically recurrent prostate cancer on androgen deprivation therapy (ADT).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Study of the Effects of Muscadine Grape Extract in Men With Biochemically Recurrent Prostate Cancer on Androgen Deprivation Therapy
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: MGE
The patients will take 4 capsules by mouth BID (twice daily).

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

Placebo Comparator: 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.
Other: Placebo
The patients will take 4 capsules by mouth BID (twice daily).

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




Primary Outcome Measures :
  1. Changes in fatigue [ Time Frame: Baseline and 6 months ]
    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.


Secondary Outcome Measures :
  1. Changes in quality of life: PROMIS [ Time Frame: Baseline and 6 months ]
    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.

  2. Changes in quality of life: HFRDIS [ Time Frame: Baseline and 6 months ]
    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.

  3. Changes in sleep disturbance [ Time Frame: Baseline and 6 months ]
    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.

  4. Changes in cognitive abilities [ Time Frame: Baseline and 6 months ]
    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.

  5. Changes in self-reported physical function [ Time Frame: Baseline and 6 months ]
    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.

  6. Changes in physical performance [ Time Frame: Baseline and 6 months ]
    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.

  7. Changes in sub-maximal exercise [ Time Frame: baseline and 6 month ]
    Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.

  8. Changes in body composition [ Time Frame: Baseline and 6 months ]
    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.

  9. Changes in prostate-specific antigen (PSA) progression [ Time Frame: baseline, 6, and 12 months ]
    PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo.

  10. Progression-free survival [ Time Frame: up to 24 months ]
    Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men age ≥18 years.
  • Histologically confirmed prostate adenocarcinoma.
  • Definitive therapy of primary prostate tumor completed. Definitive therapy can be prostatectomy, primary radiation therapy, brachytherapy, or cryotherapy. Salvage radiation after prostatectomy is allowed, if completed >30 days prior to study entry.
  • PSA greater than 0.2 ng/mL and rising on a minimum of 2 time points prior to ADT initiation. All PSA measurements must be at least 7 days apart.
  • Normal organ and marrow function as defined below:

White blood cell count >3,500/mcL Platelet count >75,000/mcL Hemoglobin >9 g/dL Total bilirubin <2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal Creatinine <2.5 X institutional upper limit of normal

  • Androgen deprivation therapy (ADT) starting <60 days prior. Prior ADT in the setting of radiation therapy permitted, as long as testosterone recovered to >100 before restarting ADT.
  • Able to ambulate (use of assist device is acceptable).
  • Able to cooperate with study-related activities.
  • The effects of MGE on the developing human fetus are unknown. Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

  • Symptomatic metastatic disease. Pelvic or retroperitoneal nodes <2 cm allowed; 3 or fewer bone metastasis allowed, provided they are asymptomatic.
  • Any cancer treatment other than ADT within 30 days prior to study entry.
  • Ongoing use of any other investigational cancer-directed agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MGE.
  • Inability to swallow oral medications.
  • Malabsorption due to bowel resection or gastrointestinal disease leading to uncontrolled diarrhea, or persistent nausea or vomiting requiring daily antiemetic therapy for symptom management within the past week.
  • Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496805


Contacts
Contact: Katherine Pleasant 3367135045 kpleasan@wakehealth.edu
Contact: Rhonda Bitting, MD 336-716-0327 rbitting@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Katherine Pleaseant    336-713-5045    kpleasan@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Rhonda Bitting, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03496805     History of Changes
Other Study ID Numbers: IRB00047840
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Wake Forest University Health Sciences:
Muscadine Grape Extract
Androgen Deprivation Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents