Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months. Secondary Objectives - To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months. - To compare quality of life in men in the MGE group compared to the placebo group. - To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group. - To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group. - To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group. OUTLINE: Participants are randomized into 1 of 2 groups. GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity. GROUP II (PLACEBO): Participants begin Androgen deprivation therapy prior to receiving placebo and then receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 72 hours and then for up to 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03496805
Study type Interventional
Source Wake Forest University Health Sciences
Contact Katherine Pleasant
Phone 3367135045
Email kpleasan@wakehealth.edu
Status Recruiting
Phase Phase 2
Start date January 29, 2019
Completion date July 2024

See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Recruiting NCT03718260 - PSMA-PET Registry for Recurrent Prostate Cancer N/A
Active, not recruiting NCT01685125 - Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00103194 - Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer Phase 2
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Recruiting NCT05304858 - Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Completed NCT02250014 - The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer N/A
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Not yet recruiting NCT06070272 - Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT01260688 - Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel Phase 2
Completed NCT01682941 - Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen N/A
Completed NCT01220817 - Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study Phase 2
Completed NCT00775866 - MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy N/A
Completed NCT00074022 - GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT05044754 - SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy
Active, not recruiting NCT01923506 - Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery Phase 1