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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Phase 2: RCT phase- Placebo | Placebo Comparator | Patients received Soybean Oil Soft Gel as the placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saw Palmetto | Drug | 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwen Wyatt, PhD, RN | MichiganState University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegiance Health | Jackson | Michigan | 49201 | United States | ||
| McLaren Greater Lansing |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules. |
| FG001 | Phase 1: Saw Palmentto Soft Gel 640mg/Day | Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules. |
| FG002 | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules. |
| FG003 | 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. |
| FG004 | Phase 2: RCT Phase- Placebo | Patients received Soybean Oil Soft Gel as the placebo treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Saw Palmetto Soft Gel 320mg/Day | Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules. |
| BG001 | Phase 1: Saw Palmetto Soft Gel 640mg/Day | Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of men who started | Posted | Count of Participants | Participants | No | Baseline to Week 12 for each phase. |
|
Adverse events were tracked with the Common Terminology Criteria for Adverse Events (CTCAE) at weeks 1 (baseline), 2-12, 14, 22 and 62.
Adverse events were tracked with the Common Terminology Criteria for Adverse Events (CTCAE) including anorexia, nausea, gastritis, hematuria, hemorrhoids, diarrhea, proctitis, pruritis/itching, and fatigue.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gwen Wyatt | Michigan State University | 517-884-4630 | gwyatt@msu.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C040972 | saw palmetto extract |
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| soybean oil soft gel | Drug | placebo (soybean oil soft gel) |
|
|
| Lansing |
| Michigan |
| 48910 |
| United States |
| Sparrow Cancer Center | Lansing | Michigan | 48912 | United States |
| McLaren Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| St. Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Phase 1: Saw Palmetto Soft Gel 960mg/Day | Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules. |
| BG003 | 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 |
| BG004 | Placebo Comparator: Phase 2: RCT Phase- Placebo | Patients received Soybean Oil Soft Gel as the placebo treatment |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Phase 1: Men in 960mg/Day DFP |
Men assigned to the 960mg/Day group in the dose finding phase. |
| OG003 | Phase 2: Saw Palmetto 960 mg RCT | Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase |
| OG004 | Phase 2: Placebo RCT | Men assigned to the placebo in the pilot RCT Phase |
|
|
| Primary | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22. |
|
|
|
| Primary | 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. | Number of participants reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm | Posted | Number | participants | Baseline to Week 12 |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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 960 mg. | 0 | 10 | 0 | 10 |
| EG002 | Phase 2: RCT Phase- Placebo | Patients received Soybean Oil Soft Gel as the placebo treatment | 0 | 11 | 0 | 11 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| FACT-P emotional well-being |
|
| FACT-P functional well-being |
|
| FACT-P physical well-being |
|
| FACT-P social well-being |
|
| FACT-P Prostate specific concern |
|