Saw Palmetto: Symptom Management for Men During Radiation Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type OTHER

Saw Palmetto

Intervention Type DRUG

1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)

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.

Group Type ACTIVE_COMPARATOR

Saw Palmetto

Intervention Type DRUG

1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)

Phase 2: RCT phase- Placebo

Patients received Soybean Oil Soft Gel as the placebo treatment

Group Type PLACEBO_COMPARATOR

soybean oil soft gel

Intervention Type DRUG

placebo (soybean oil soft gel)

Interventions

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Saw Palmetto

1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)

Intervention Type DRUG

soybean oil soft gel

placebo (soybean oil soft gel)

Intervention Type DRUG

Other Intervention Names

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SP Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No