Saw Palmetto: Symptom Management for Men During Radiation Therapy

September 26, 2019 updated by: Gwen Wyatt, Michigan State University

Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Lansing, Michigan, United States, 48912
        • Sparrow Cancer Center
      • Lansing, Michigan, United States, 48910
        • McLaren Greater Lansing
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Macomb
      • Mount Pleasant, Michigan, United States, 48858
        • McLaren Central Michigan
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy Oakland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Phase 1: The dose finding phase (DFP)
Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
Drug: Saw Palmetto
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Other Names:
  • SP
Active Comparator: Phase 2: RCT phase- Saw Palmetto
Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
Drug: Saw Palmetto
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Other Names:
  • SP
Placebo Comparator: Phase 2: RCT phase- Placebo
Patients received Soybean Oil Soft Gel as the placebo treatment
Drug: soybean oil soft gel
placebo (soybean oil soft gel)
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 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.
Baseline to Week 12 for each phase.
Efficacy
Time Frame: 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.
HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.
Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose
Time Frame: 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.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Investigators

  • Principal Investigator: Gwen Wyatt, PhD, RN, MichiganState University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Application ID 213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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