COMPLETED

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

Conditions

Recurrent Prostate Cancer Muscadine Grape Extract Androgen Deprivation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-01-29

Study Completion:2025-08-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03496805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: * 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).	* 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.

Inclusion Criteria

Exclusion Criteria

* 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:
* 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).

* 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.

Contacts and Locations

Principal Investigator

Heidi Klepin, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

WG Hefner VA Medical Center

Salisbury, North Carolina, 28144

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Heidi Klepin, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-29

Study Completion Date2025-08-17

Study Record Updates

Study Start Date2019-01-29

Study Completion Date2025-08-17

Terms related to this study

Keywords Provided by Researchers

Muscadine Grape Extract
Androgen Deprivation Therapy

Additional Relevant MeSH Terms

Recurrent Prostate Cancer