Trial Outcomes & Findings for Saw Palmetto: Symptom Management for Men During Radiation Therapy (NCT NCT01585246)
NCT ID: NCT01585246
Last Updated: 2019-09-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline to Week 12 for each phase.
Results posted on
2019-09-30
Participant Flow
Participant milestones
| Measure |
Phase 1: Saw Palmetto Soft Gel 320mg/Day
Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmentto Soft Gel 640mg/Day
Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmetto Soft Gel 960mg/Day
Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
|
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.
|
Phase 2: RCT Phase- Placebo
Patients received Soybean Oil Soft Gel as the placebo treatment
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
20
|
10
|
11
|
|
Overall Study
COMPLETED
|
3
|
3
|
16
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
4
|
2
|
Reasons for withdrawal
| Measure |
Phase 1: Saw Palmetto Soft Gel 320mg/Day
Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmentto Soft Gel 640mg/Day
Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmetto Soft Gel 960mg/Day
Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
|
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.
|
Phase 2: RCT Phase- Placebo
Patients received Soybean Oil Soft Gel as the placebo treatment
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Saw Palmetto: Symptom Management for Men During Radiation Therapy
Baseline characteristics by cohort
| Measure |
Phase 1: Saw Palmetto Soft Gel 320mg/Day
n=3 Participants
Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmetto Soft Gel 640mg/Day
n=4 Participants
Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
|
Phase 1: Saw Palmetto Soft Gel 960mg/Day
n=20 Participants
Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
|
Active Comparator: Phase 2: RCT Phase- Saw Palmetto
n=10 Participants
Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg
|
Placebo Comparator: Phase 2: RCT Phase- Placebo
n=11 Participants
Patients received Soybean Oil Soft Gel as the placebo treatment
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
62.75 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
66.70 years
STANDARD_DEVIATION 11.30 • n=4 Participants
|
67.82 years
STANDARD_DEVIATION 7.22 • n=21 Participants
|
67.29 years
STANDARD_DEVIATION 9.16 • n=10 Participants
|
|
Sex/Gender, Customized
Male
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
20 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
48 participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
20 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
48 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 for each phase.Population: Number of men who started
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.
Outcome measures
| Measure |
Phase 1: Men in 320mg/Day DFP
n=3 Participants
Men assigned to the 320mg/Day group in the dose finding phase.
|
Phase 1: Men in 640mg/Day DFP
n=4 Participants
Men assigned to the 640mg/Day group in the dose finding phase.
|
Phase 1: Men in 960mg/Day DFP
n=20 Participants
Men assigned to the 960mg/Day group in the dose finding phase.
|
Phase 2: Saw Palmetto 960 mg RCT
n=10 Participants
Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
|
Phase 2: Placebo RCT
n=11 Participants
Men assigned to the placebo in the pilot RCT Phase
|
|---|---|---|---|---|---|
|
Feasibility
|
3 Participants
|
3 Participants
|
16 Participants
|
6 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Phase 1: Men in 320mg/Day DFP
n=6 Participants
Men assigned to the 320mg/Day group in the dose finding phase.
|
Phase 1: Men in 640mg/Day DFP
n=9 Participants
Men assigned to the 640mg/Day group in the dose finding phase.
|
Phase 1: Men in 960mg/Day DFP
Men assigned to the 960mg/Day group in the dose finding phase.
|
Phase 2: Saw Palmetto 960 mg RCT
Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
|
Phase 2: Placebo RCT
Men assigned to the placebo in the pilot RCT Phase
|
|---|---|---|---|---|---|
|
Efficacy
FACT-P Prostate specific concern
|
35.13 units on a scale
Standard Deviation 1.92
|
33.81 units on a scale
Standard Deviation 1.82
|
—
|
—
|
—
|
|
Efficacy
IPSS
|
10.54 units on a scale
Standard Deviation 1.29
|
9.41 units on a scale
Standard Deviation 1.21
|
—
|
—
|
—
|
|
Efficacy
FACT-P total
|
124.77 units on a scale
Standard Deviation 4.37
|
124.48 units on a scale
Standard Deviation 4.18
|
—
|
—
|
—
|
|
Efficacy
FACT-P emotional well-being
|
20.77 units on a scale
Standard Deviation 0.84
|
21.62 units on a scale
Standard Deviation 0.79
|
—
|
—
|
—
|
|
Efficacy
FACT-P functional well-being
|
22.24 units on a scale
Standard Deviation 1.30
|
21.20 units on a scale
Standard Deviation 1.25
|
—
|
—
|
—
|
|
Efficacy
FACT-P physical well-being
|
24.00 units on a scale
Standard Deviation 0.86
|
25.67 units on a scale
Standard Deviation 0.81
|
—
|
—
|
—
|
|
Efficacy
FACT-P social well-being
|
23.38 units on a scale
Standard Deviation 1.08
|
21.02 units on a scale
Standard Deviation 1.01
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Number of participants reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm
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.
Outcome measures
| Measure |
Phase 1: Men in 320mg/Day DFP
n=3 Participants
Men assigned to the 320mg/Day group in the dose finding phase.
|
Phase 1: Men in 640mg/Day DFP
n=3 Participants
Men assigned to the 640mg/Day group in the dose finding phase.
|
Phase 1: Men in 960mg/Day DFP
n=16 Participants
Men assigned to the 960mg/Day group in the dose finding phase.
|
Phase 2: Saw Palmetto 960 mg RCT
Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
|
Phase 2: Placebo RCT
Men assigned to the placebo in the pilot RCT Phase
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
Phase 1: The Dose Finding Phase (DFP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: RCT Phase- Saw Palmetto
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: RCT Phase- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place