Saw Palmetto: Symptom Management for Men During Radiation Therapy

NCT01585246 | Completed Phase 1 Results DMC

• 1 other identifier: Application ID 213
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radiation Therapy; Quality of Life; Symptom Management

Outcome Measures

Primary Outcomes (3)

• Feasibility

  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.

  Baseline to Week 12 for each phase.

• Efficacy

  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.

  HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.

• Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose

  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.

  Baseline to Week 12

Study Arms (3)

Phase 1: The dose finding phase (DFP)

OTHER

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

Drug: Saw Palmetto

Phase 2: RCT phase- Saw Palmetto

ACTIVE COMPARATOR

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

Drug: Saw Palmetto

Phase 2: RCT phase- Placebo

PLACEBO COMPARATOR

Patients received Soybean Oil Soft Gel as the placebo treatment

Drug: soybean oil soft gel

Interventions

Saw Palmetto DRUG

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

Also known as: SP

Phase 1: The dose finding phase (DFP); Phase 2: RCT phase- Saw Palmetto

soybean oil soft gel DRUG

placebo (soybean oil soft gel)

Also known as: Placebo

Phase 2: RCT phase- Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (6)

Allegiance Health

Jackson, Michigan, 49201, United States

Location

McLaren Greater Lansing

Lansing, Michigan, 48910, United States

Location

Sparrow Cancer Center

Lansing, Michigan, 48912, United States

Location

McLaren Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

saw palmetto extract

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Gwen Wyatt
• Organization: Michigan State University

gwyatt@msu.edu

517-884-4630

Study Officials

• Gwen Wyatt, PhD, RN

  MichiganState University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 30, 2019
• Results First Posted: July 14, 2017

Record last verified: 2019-09

Locations

US (6)