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Saw Palmetto: Symptom Management for Men During Radiation Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585246
First Posted: April 25, 2012
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
April 23, 2012
April 25, 2012
May 4, 2016
July 14, 2017
August 11, 2017
October 2011
April 2015   (Final data collection date for primary outcome measure)
  • Feasibility [ Time Frame: Baseline to Week 12 for each phase. ]
    Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.
  • Efficacy [ Time Frame: HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22. ]
    Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health-Related Quality of life (HRQOL) including physical functioning and symptoms. The outcomes were measured using 1) the International Prostate Symptoms Score (IPSS) and 2) the total and subscales of the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The IPSS which ranges from 0-35. A lower score indicates better symptoms. The FACT-P has the following subscores and ranges: emotional well-being (0-24), functional well-being (0-28), physical well-being (0-28), social well-being (0-28), and prostate-specific concerns (0-48). The FACT-P total is comprised of the sum of the subscales and ranges from 0-156. For the FACT-P, a higher score indicates better quality of life. Each values was created as an average over time from a linear mixed effects model that adjusted for baseline values.
  • Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose [ Time Frame: Baseline to Week 12 ]
    Dose limiting toxicities was defined as the Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher for gastrointestinal symptoms (nausea, gastritis, anorexia). The maximum tolerated dose (MTD) was established among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms.
  • Feasibility [ Time Frame: Baseline to Week 12 ]
    Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.
  • Efficacy [ Time Frame: Baseline to Week 22 ]
    Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health Related Quality of life (HRQOL) including physical functioning.
  • Safety [ Time Frame: Baseline to Week 22 ]
    Establishing the maximum tolerated dose (MTD) among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms. Also, by comparing PSA and blood chemistry levels at 6 weeks and post-Saw Palmetto treatment to the corresponding levels in the placebo group.
Complete list of historical versions of study NCT01585246 on ClinicalTrials.gov Archive Site
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Saw Palmetto: Symptom Management for Men During Radiation Therapy
Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Saw Palmetto
    1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
    Other Name: SP
  • Drug: soybean oil soft gel
    placebo (soybean oil soft gel)
    Other Name: Placebo
  • 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
    Intervention: Drug: Saw Palmetto
  • Active Comparator: 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.
    Intervention: Drug: Saw Palmetto
  • Placebo Comparator: Phase 2: RCT phase- Placebo
    Patients received Soybean Oil Soft Gel as the placebo treatment
    Intervention: Drug: soybean oil soft gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2015
April 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01585246
Application ID 213
Yes
Not Provided
Plan to Share IPD: Undecided
Gwen Wyatt, Michigan State University
Michigan State University
Not Provided
Principal Investigator: Gwen Wyatt, PhD, RN MichiganState University
Michigan State University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP