Saw Palmetto: Symptom Management for Men During Radiation Therapy

Michigan State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Saw Palmetto; Drug: soybean oil soft gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01585246

Application ID 213

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Phase 1: The dose finding phase (DFP)

Other group

Description:

Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose

Treatment:

Drug: Saw Palmetto

Phase 2: RCT phase- Saw Palmetto

Active Comparator group

Description:

Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.

Treatment:

Drug: Saw Palmetto

Phase 2: RCT phase- Placebo

Placebo Comparator group

Description:

Patients received Soybean Oil Soft Gel as the placebo treatment

Treatment:

Drug: soybean oil soft gel