Back to resultsSaw Palmetto: Symptom Management for Men During Radiation Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Saw Palmetto
soybean oil soft gel
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Radiation Therapy, Quality of Life, Symptom Management
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)
Sites / Locations
- Allegiance Health
- McLaren Greater Lansing
- Sparrow Cancer Center
- McLaren Macomb
- McLaren Central Michigan
- St. Joseph Mercy Oakland Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Placebo Comparator
Arm Label
Phase 1: The dose finding phase (DFP)
Phase 2: RCT phase- Saw Palmetto
Phase 2: RCT phase- Placebo
Arm Description
Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
Patients received Soybean Oil Soft Gel as the placebo treatment
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01585246
First Posted
April 23, 2012
Last Updated
September 26, 2019
Sponsor
Michigan State University
1. Study Identification
Unique Protocol Identification Number
NCT01585246
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Radiation Therapy, Quality of Life, Symptom Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1: The dose finding phase (DFP)
Arm Type
Other
Arm Description
Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
Arm Title
Phase 2: RCT phase- Saw Palmetto
Arm Type
Active Comparator
Arm Description
Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
Arm Title
Phase 2: RCT phase- Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received Soybean Oil Soft Gel as the placebo treatment
Intervention Type
Drug
Intervention Name(s)
Saw Palmetto
Other Intervention Name(s)
SP
Intervention Description
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Intervention Type
Drug
Intervention Name(s)
soybean oil soft gel
Other Intervention Name(s)
Placebo
Intervention Description
placebo (soybean oil soft gel)
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
Baseline to Week 12 for each phase.
Title
Efficacy
Description
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.
Time Frame
HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.
Title
Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose
Description
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.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen Wyatt, PhD, RN
Organizational Affiliation
MichiganState University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
McLaren Greater Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Sparrow Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
McLaren Macomb
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
McLaren Central Michigan
City
Mount Pleasant
State/Province
Michigan
ZIP/Postal Code
48858
Country
United States
Facility Name
St. Joseph Mercy Oakland Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Saw Palmetto: Symptom Management for Men During Radiation Therapy
We'll reach out to this number within 24 hrs