This trial is active, not recruiting.

Condition prostate cancer
Treatment saw palmetto
Phase phase 1/phase 2
Sponsor Michigan State University
Start date October 2011
End date April 2015
Trial size 60 participants
Trial identifier NCT01585246, Application ID 213


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Active Comparator)
saw palmetto
either placebo (soybean oil soft gel) or 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
(Placebo Comparator)
saw palmetto
either placebo (soybean oil soft gel) or 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)

Primary Outcomes

time frame: Baseline to Week 12
time frame: Baseline to Week 22
time frame: Baseline to Week 22

Eligibility Criteria

Male participants at least 21 years old.

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)

Additional Information

Official title Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients
Principal investigator Gwen Wyatt, PhD, RN
Description Lower urinary tract symptoms (LUTS) affect from 75-80% of men undergoing radiation therapy (RT) for prostate cancer. The purpose of this study is to determine the feasibility, safety and efficacy of an inexpensive, non-toxic herbal supplement, Saw Palmetto, in treating these distressing symptoms. This trial will use a two group randomized design: either placebo or 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day) to determine the maximum therapeutic dose (MTD), and obtain preliminary evidence of efficacy. Within the Saw Palmetto arm, men will be allocated to 1 of the 3 the doses using the Time-to-Event Continual Reassessment Method and will continue with the same dose for the 12 week protocol. Safety data will consist of the Common Terminology for Adverse Events criteria for nausea, gastritis, and anorexia. Efficacy of the MTD will be evaluated by weekly symptom data and voiding diary. A pill diary will be used to ensure intervention fidelity. This study has the potential to reduce the incidence of LUTS for men during RT for cancer of the prostate and ultimately improve their quality of life during the acute phase of treatment.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Michigan State University.