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Hormone Therapy
MGE + ADT for Prostate Cancer
Phase 2
Recruiting
Led By Heidi Klepin, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed prostate adenocarcinoma
Be older than 18 years old
Must not have
Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone)
Inability to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, and 12 months
Awards & highlights
Summary
This trial is testing whether adding muscadine grape extract to androgen deprivation therapy improves symptoms in men with prostate cancer.
Who is the study for?
This trial is for English-speaking men over 18 with prostate cancer who are on androgen deprivation therapy (ADT) and expected to continue it for the next year. They must have normal organ function, be able to walk, cooperate with study activities, use contraception, and sign a consent form. Men with symptomatic metastatic disease, recent surgery or radiation, rising PSA levels while on current therapy, plans to stop ADT or start chemotherapy within a year can't join.
What is being tested?
The trial tests if adding muscadine grape extract (MGE), known for its anti-inflammatory and antioxidant properties, to standard ADT improves symptoms in men with prostate cancer. Participants will either receive MGE or a placebo alongside their ongoing ADT treatment.
What are the potential side effects?
Potential side effects of MGE may include allergic reactions similar to those from compounds of like chemical structure. The study excludes individuals who have had allergic reactions attributed to such compounds.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a tissue examination.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have painful cancer spread that needs treatment.
Select...
I cannot swallow pills.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have severe digestion issues causing uncontrolled symptoms despite daily treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in fatigue
Secondary study objectives
Changes in body composition
Changes in cognitive abilities
Changes in physical performance
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MGE groupExperimental Treatment2 Interventions
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.
Group II: Placebo groupPlacebo Group2 Interventions
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,547 Total Patients Enrolled
21 Trials studying Prostate Cancer
1,769 Patients Enrolled for Prostate Cancer
Heidi Klepin, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
141 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk, even if I need a device to help me.I am a man, 18 or older, and speak English fluently.I plan to stop hormone therapy or start chemotherapy within a year of joining the study.You are currently taking any other experimental cancer treatments.I have painful cancer spread that needs treatment.I can understand and am willing to sign the consent form.I cannot swallow pills.My prostate cancer was confirmed through a tissue examination.I have not had prostate cancer surgery or radiation in the last 60 days.You have had allergic reactions in the past to similar substances as MGE.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My PSA levels have increased by more than 0.5 ng/mL while on prostate cancer treatment.I have severe digestion issues causing uncontrolled symptoms despite daily treatment.I agree to use effective birth control or remain abstinent during the study.My recent tests show my organs and bone marrow are functioning well.I am undergoing or have had treatment to lower my testosterone levels for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: MGE group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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