Saw Palmetto: Symptom Management for Men During Radiation Therapy

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01585246

Run by

Michigan State University

People needed

48

Starts

2011-10-01

Expected to finish

2015-04-01

Last updated by the study team

2019-09-30

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Allegiance Health — Jackson, Michigan, United States
• McLaren Greater Lansing — Lansing, Michigan, United States
• Sparrow Cancer Center — Lansing, Michigan, United States
• McLaren Macomb — Mount Clemens, Michigan, United States
• McLaren Central Michigan — Mount Pleasant, Michigan, United States
• St. Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States

Full record on ClinicalTrials.gov

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