A Phase 1/2 interventional study of Saw Palmetto and soybean oil soft gel in Prostate Cancer, sponsored by Michigan State University. Completed at 6 sites in United States. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Michigan State University · Phase 1/2, Interventional, and Treatment
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.
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This study's enrollment of 48 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
Drug: 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
Patients received Soybean Oil Soft Gel as the placebo treatment
Drug: soybean oil soft gel
1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
Also known as: SP
placebo (soybean oil soft gel)
Also known as: Placebo
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12
| Milestone | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmentto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Phase 2: RCT Phase- Saw Palmetto | Phase 2: RCT Phase- Placebo |
|---|---|---|---|---|---|
| Started | 3 | 4 | 20 | 10 | 11 |
| Completed | 3 | 3 | 16 | 6 | 9 |
| Not completed | 0 | 1 | 4 | 4 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Other | 0 | 1 | 1 | 1 | 0 |
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.
| Participants | Phase 1: Men in 320mg/Day DFP | Phase 1: Men in 640mg/Day DFP | Phase 1: Men in 960mg/Day DFP | Phase 2: Saw Palmetto 960 mg RCT | Phase 2: Placebo RCT |
|---|---|---|---|---|---|
| Feasibility | 3 | 3 | 16 | 6 | 9 |
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.
| units on a scale | Phase 2: RCT Phase- Saw Palmetto | Phase 2: RCT Phase- Placebo |
|---|---|---|
| IPSS | 10.54 ± 1.29 | 9.41 ± 1.21 |
| FACT-P total | 124.77 ± 4.37 | 124.48 ± 4.18 |
| FACT-P emotional well-being | 20.77 ± 0.84 | 21.62 ± 0.79 |
| FACT-P functional well-being | 22.24 ± 1.30 | 21.20 ± 1.25 |
| FACT-P physical well-being | 24.00 ± 0.86 | 25.67 ± 0.81 |
| FACT-P social well-being | 23.38 ± 1.08 | 21.02 ± 1.01 |
| FACT-P Prostate specific concern | 35.13 ± 1.92 | 33.81 ± 1.82 |
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.
| participants | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase I: Saw Palmetto Soft Gel 640mg/Day | Phase I: Saw Palmetto Soft Gel 960mg/Day |
|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose | 0 | 0 | 0 |
Collected over Adverse events were tracked with the Common Terminology Criteria for Adverse Events (CTCAE) at weeks 1 (baseline), 2-12, 14, 22 and 62.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: The Dose Finding Phase (DFP) | — | 0/27 (0%) | 0/27 (0%) |
| Phase 2: RCT Phase- Saw Palmetto | — | 0/10 (0%) | 0/10 (0%) |
| Phase 2: RCT Phase- Placebo | — | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Active Comparator: Phase 2: RCT Phase- Saw Palmetto | Placebo Comparator: Phase 2: RCT Phase- Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 71 ± 3.0 | 62.75 ± 12.09 | 62.1 ± 5.3 | 66.70 ± 11.30 | 67.82 ± 7.22 | 67.29 ± 9.16 |
| Sex/Gender, Customized(participants) | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Active Comparator: Phase 2: RCT Phase- Saw Palmetto | Placebo Comparator: Phase 2: RCT Phase- Placebo | Total |
|---|---|---|---|---|---|---|
| Male | 3 | 4 | 20 | 10 | 11 | 48 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Active Comparator: Phase 2: RCT Phase- Saw Palmetto | Placebo Comparator: Phase 2: RCT Phase- Placebo | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 3 | 4 | 14 | 8 | 8 | 37 |
| Unknown or Not Reported | 0 | 0 | 5 | 2 | 3 | 10 |
| Race (NIH/OMB)(Participants) | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Active Comparator: Phase 2: RCT Phase- Saw Palmetto | Placebo Comparator: Phase 2: RCT Phase- Placebo | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 2 | 1 | 0 | 3 |
| White | 3 | 4 | 15 | 9 | 10 | 41 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 3 | 0 | 1 | 4 |
| Region of Enrollment(participants) | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Active Comparator: Phase 2: RCT Phase- Saw Palmetto | Placebo Comparator: Phase 2: RCT Phase- Placebo | Total |
|---|---|---|---|---|---|---|
| United States | 3 | 4 | 20 | 10 | 11 | 48 |
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