Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Wake Forest University Health Sciences
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
