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Effects of Muscadine Grape Extract in Men With 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 : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Changes in sub-maximal exercise [ Time Frame: baseline and 6 month ]
    Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.
  • 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.
  • 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.
  • Progression-free survival [ Time Frame: up to 12 months ]
    Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Changes in sub-maximal exercise [ Time Frame: baseline and 6 month ]
    Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
Official Title  ICMJE A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Recurrent Prostate Cancer
Intervention  ICMJE
  • Drug: MGE
    The patients will take 4 capsules by mouth BID (twice daily).
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: MGE
    • Other: ADT
  • 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.
    Interventions:
    • Other: Placebo
    • Other: ADT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
160
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
192
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men age ≥18 years who are fluent in English.
  • 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 >60 days prior to study entry.
  • Prior surgical castration or active use of androgen deprivation therapy (ADT) alone, with expectation by the treating physician that patient would remain on ADT alone for upcoming 12 months, without escalating therapy. Prior ADT in the setting of definitive radiation therapy permitted.
  • Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below:

White blood cell count >3,500/mcL (or 3.5 (x103)) Platelet count >75,000/mcL (or 75 (x103)) 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

  • 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.
  • Any cancer treatment other than ADT within 30 days prior to study entry.
  • Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on continuous ADT determined by PSA values, at least one of which must be during the 6 months prior to study entry PSA values must be at least 7 days apart.
  • Planned cessation of ADT or planned escalation of prostate cancer therapy within 12 months after 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine Pleasant 3367135045 kpleasan@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03496805
Other Study ID Numbers  ICMJE IRB00047840
CCCWFU 85417 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heidi Klepin, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP