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

NCT03496805 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00047840CCCWFU 85417
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Prostate Cancer

Keywords

Muscadine Grape Extract; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Changes in Quality of Life: PROMIS

  Baseline and 6 months

• Changes in Quality of Life: HFRDIS

  Baseline and 6 months

• Changes in Sleep Disturbance

  Baseline and 6 months

• Changes in Cognitive Abilities

  Baseline and 6 months

• Changes in Self-reported Physical Function

  Baseline and 6 months

Study Arms (2)

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.

Drug: MGE; Other: ADT

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.

Other: Placebo; Other: ADT

Interventions

MGE DRUG

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

MGE group

Placebo OTHER

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

Placebo group

ADT OTHER

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

MGE group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men age ≥18 years who are fluent in English.
• Histologically confirmed prostate adenocarcinoma.
• Prior surgical castration or active ongoing use of androgen deprivation therapy (ADT) with expectation by the treating physician that patient would remain on ADT for the upcoming 12 months. ADT in the setting of definitive radiation therapy permitted. Concurrent treatment with androgen pathway inhibitors (examples include enzalutamide, abiraterone, darolutamide, apalutamide) permitted..
• Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below:
• 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
• 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).

You may not qualify if:

• Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone).
• Prostate cancer related surgery or radiation within 60 days prior to study entry.
• Documented rise in PSA (defined as rise of \> 0.5 ng/mL) while on current prostate cancer therapy, 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 use of cytotoxic chemotherapy (i.e., docetaxel) 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

WG Hefner VA Medical Center

Salisbury, North Carolina, 28144, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

mvelasqu@wakehealth.edu

3367135045

Study Officials

• Heidi Klepin, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: January 29, 2019
• Primary Completion: February 20, 2025
• Study Completion: August 14, 2025
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)