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

Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.

Phase 1: Saw Palmetto Soft Gel 320mg/Day

Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.

Phase 1: Saw Palmetto Soft Gel 640mg/Day

Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.

Phase 1: Saw Palmetto Soft Gel 960mg/Day

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

Active Comparator: Phase 2: RCT Phase- Saw Palmetto

Placebo Comparator: Phase 2: RCT Phase- Placebo

Total

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

Men assigned to the 320mg/Day group in the dose finding phase.

Phase 1: Men in 320mg/Day DFP

Men assigned to the 640mg/Day group in the dose finding phase.

Phase 1: Men in 640mg/Day DFP

Men assigned to the 960mg/Day group in the dose finding phase.

Phase 1: Men in 960mg/Day DFP

Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase

Phase 2: Saw Palmetto 960 mg RCT

Men assigned to the placebo in the pilot RCT Phase

Phase 2: Placebo RCT

Feasibility

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.

Phase 2: RCT Phase- Saw Palmetto

Phase 2: RCT Phase- Placebo

Efficacy

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.

Phase I: Saw Palmetto Soft Gel 640mg/Day

Participants in this arm received 960 mg/day of Saw Palmetto Soft Gel capsules.

Phase I: Saw Palmetto Soft Gel 960mg/Day

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

Phase 1: Saw Palmentto Soft Gel 640mg/Day

Overall Study

Dr. Gwen Wyatt

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

Phase 1: The Dose Finding Phase (DFP)

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

Prostate Cancer

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

Saw Palmetto

soybean oil soft gel

Allegiance Health

McLaren Greater Lansing

Sparrow Cancer Center

McLaren Macomb

McLaren Central Michigan

St. Joseph Mercy Oakland Hospital

Saw Palmetto: Symptom Management for Men During Radiation Therapy

Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients

Gwen Wyatt

Professor

Michigan State University

A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.

Prepidil Only : Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.

A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.

A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device.

Urinary Balloon Catheter Only

Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.

Prepadil Only

A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.

Combined Urinary Catheter & Prepadil Gel

Sex: Female, Male

The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.

Vaginal Delivery

Meg Hill, MBBS

Failed Labour

Pre-induction cervical ripening using dinoprostone gel in the vagina.

Prepidil Gel

Pre-induction cervical ripening using a urinary balloon catheter device.

Urinary Balloon Catheter

Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.

sabal miamiensis/nauzea

Saw Palmetto: Symptom Management for Men During Radiation Therapy

Comparison of Pre-Induction Cervical Ripening

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