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Saw Palmetto: Symptom Management for Men During Radiation Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
ClinicalTrials.gov Identifier:
NCT01585246
First received: April 23, 2012
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Saw Palmetto Drug: soybean oil soft gel Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Gwen Wyatt, Michigan State University:

Primary Outcome Measures:
  • 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.


Enrollment: 48
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Saw Palmetto
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Other Name: SP
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.
Drug: Saw Palmetto
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Other Name: SP
Placebo Comparator: Phase 2: RCT phase- Placebo
Patients received Soybean Oil Soft Gel as the placebo treatment
Drug: soybean oil soft gel
placebo (soybean oil soft gel)
Other Name: Placebo

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585246

Locations
United States, Michigan
Allegiance Health
Jackson, Michigan, United States, 49201
McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Sparrow Cancer Center
Lansing, Michigan, United States, 48912
McLaren Macomb
Mount Clemens, Michigan, United States, 48043
McLaren Central Michigan
Mount Pleasant, Michigan, United States, 48858
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Gwen Wyatt, PhD, RN MichiganState University
  More Information

Responsible Party: Gwen Wyatt, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01585246     History of Changes
Other Study ID Numbers: Application ID 213
Study First Received: April 23, 2012
Results First Received: May 4, 2016
Last Updated: July 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gwen Wyatt, Michigan State University:
Prostate Cancer
Radiation Therapy
Quality of Life
Symptom Management

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Permixon
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists

ClinicalTrials.gov processed this record on September 20, 2017