Clinical trial NCT01585246: Saw Palmetto: Symptom Management for Men During Radiation Therapy
Official title: Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radiation Therapy
Quality of Life
Symptom Management
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 48
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Feasibility
timeFrame: Baseline to Week 12 for each phase.
measure: Efficacy
timeFrame: HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.
measure: Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Mount Pleasant
country: United States
facility: McLaren Central Michigan
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
Study officials:
affiliation: MichiganState University
name: Gwen Wyatt, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: