Muscadine grape extract for men with prostate cancer on hormone therapy
A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
This study is testing whether muscadine grape extract can help reduce fatigue and improve quality of life for men with recurrent prostate cancer who are on hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Salisbury, North Carolina and 1 other locations) |
| Trial ID | NCT03496805 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of muscadine grape extract (MGE) on men undergoing androgen deprivation therapy (ADT) for recurrent prostate cancer. Participants are randomly assigned to receive either MGE or a placebo alongside their ADT for 12 months. The primary focus is to assess fatigue levels at 6 months, with secondary objectives including quality of life, physical function, body composition, and progression-free survival. The study aims to build on previous evidence suggesting that grape extracts may have beneficial effects on cancer treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed prostate adenocarcinoma currently on or expected to remain on androgen deprivation therapy.
Not a fit: Patients who are not fluent in English or have contraindications to muscadine grape extract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and reduce fatigue in men undergoing treatment for prostate cancer.
How similar studies have performed: Previous studies have shown promising results with grape extracts in cancer treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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: 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). Exclusion Criteria: * 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.
Where this trial is running
Salisbury, North Carolina and 1 other locations
- WG Hefner VA Medical Center — Salisbury, North Carolina, United States (Recruiting)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Heidi Klepin, MD — Wake Forest University Health Sciences
- Study coordinator: Katherine Pleasant
- Email: kpleasan@wakehealth.edu
- Phone: 3367135045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.