Phase 2 Completed N=48 Randomized Double-blind Treatment

Saw Palmetto: Symptom Management for Men During Radiation Therapy

Prostate Cancer

Source: ClinicalTrials.gov NCT01585246 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcomePrimary: Feasibility — 3; 3; 16; 6 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility	3; 3; 16; 6; 9	—
PRIMARY Efficacy	10.54; 9.41; 124.77; 124.48; 20.77; 21.62	—
PRIMARY Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose	0; 0; 0	—

Eligibility 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)

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Data sourced from ClinicalTrials.gov (NCT01585246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.