Grape extract shows promise for easing fatigue in prostate cancer patients
NCT ID NCT03496805
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a supplement made from muscadine grapes could reduce fatigue and improve quality of life in 106 men with prostate cancer who were already receiving hormone therapy (androgen deprivation therapy). Participants took either the grape extract or a placebo for several months. The goal was to see if the extract could ease common side effects of hormone therapy, like tiredness, without interfering with cancer treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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106 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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WG Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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