Saw Palmetto: Symptom Management for Men During Radiation Therapy

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Drug: Saw Palmetto
Drug: soybean oil soft gel

Registration Number: NCT01585246

Lead Sponsor: Michigan State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 48

Inclusion Criteria

Age 21 years or older
Adenocarcinoma of the prostate
Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml
Combined Gleason Score ≤ 8
Karnofsky level of performance of > 70%
Consented to undergo definitive Radiation Therapy

Exclusion Criteria

Stage T4 or M1
Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen).
Prior pelvic radiation therapy
Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase.
Uncontrolled hypertension despite use of antihypertensive medication
Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1: The dose finding phase (DFP)	Saw Palmetto	Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
Phase 2: RCT phase- Saw Palmetto	Saw Palmetto	Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
Phase 2: RCT phase- Placebo	soybean oil soft gel	Patients received Soybean Oil Soft Gel as the placebo treatment

Primary Outcome Measures

Name	Time	Method
Efficacy	HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.	Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health-Related Quality of life (HRQOL) including physical functioning and symptoms. The outcomes were measured using 1) the International Prostate Symptoms Score (IPSS) and 2) the total and subscales of the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The IPSS which ranges from 0-35. A lower score indicates better symptoms. The FACT-P has the following subscores and ranges: emotional well-being (0-24), functional well-being (0-28), physical well-being (0-28), social well-being (0-28), and prostate-specific concerns (0-48). The FACT-P total is comprised of the sum of the subscales and ranges from 0-156. For the FACT-P, a higher score indicates better quality of life. Each values was created as an average over time from a linear mixed effects model that adjusted for baseline values.
Feasibility	Baseline to Week 12 for each phase.	Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.
Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose	Baseline to Week 12	Dose limiting toxicities was defined as the Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher for gastrointestinal symptoms (nausea, gastritis, anorexia). The maximum tolerated dose (MTD) was established among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (6): St. Joseph Mercy Oakland Hospital
🇺🇸
Pontiac, Michigan, United States
Allegiance Health
🇺🇸
Jackson, Michigan, United States
McLaren Macomb
🇺🇸
Mount Clemens, Michigan, United States
McLaren Central Michigan
🇺🇸
Mount Pleasant, Michigan, United States
McLaren Greater Lansing
🇺🇸
Lansing, Michigan, United States
Sparrow Cancer Center
🇺🇸
Lansing, Michigan, United States