Conditions: Prostate Cancer
Keywords: Prostate Cancer Radiation Therapy Quality of Life Symptom Management
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms will be recorded each week, as well as assessment of quality of life through: 1) Physical Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.

Detailed description:
Lower urinary tract symptoms (LUTS) affect from 75-80% of men undergoing radiation therapy (RT) for prostate cancer. The purpose of this study was to determine the feasibility, safety and efficacy of inexpensive, non-toxic herbal supplement, Saw Palmetto (SP), in treating these distressing symptoms.

The study consisted of two phases: Dose Finding phase (DFP), and Exploratory Randomized Controlled Trail (RCT) phase. In the 12 week DFP, participants were given one of three doses (SP 320 mg, SP 640mg, and SP 960 mg) using the Time-to-Event Continual Reassessment Method to determine the maximum therapeutic dose (MTD). Once the MTD was determined the RCT phase was begun, participants were allocated to receive either the predetermined MTD (960 mg) in the DFP or a placebo to obtain preliminary evidence of efficacy of SP on LUTS.

Safety data consisted of the Common Terminology for Adverse Events criteria for nausea, gastritis, and anorexia. Efficacy of the MTD was evaluated by weekly symptom data and voiding diary. A pill diary was used to ensure the intervention fidelity.

Arms:
arm 1: Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose arm 2: Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg. arm 3: Patients received Soybean Oil Soft Gel as the placebo treatment

Interventions: intervention 1: Saw Palmetto intervention 2: soybean oil soft gel
Intervention descriptions: intervention 1: 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day) intervention 2: placebo (soybean oil soft gel)

Protocol document: