Saw Palmetto: Symptom Management for Men During Radiation Therapy

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michigan State University
• Treatments: Permixon; Saw palmetto extract

Criteria

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)