Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Urological Agents

All Drugs and Chemicals

Herbal and Botanical

Saw palmetto extract

Soy Bean

Saw Palmetto

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

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

soybean oil soft gel

Gwen Wyatt, PhD, RN

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.

Saw Palmetto: Symptom Management for Men During Radiation Therapy

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

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.

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.

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.

Michigan State University

Professor

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.

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.

Phase 2: RCT Phase- Saw Palmetto

Phase 2: RCT Phase- Placebo

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

Age, Continuous

Male

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Gwen Wyatt

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

IPSS

FACT-P total

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

Efficacy

The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.

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 reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Saw Palmetto: Symptom Management for Men During Radiation Therapy	NCT01585246	Prostate Cancer	Saw Palmetto soybean oil sof...	21 Years -	Michigan State University
Saw Palmetto: Symptom Management for Men During Radiation Therapy	NCT01585246	Prostate Cancer	Saw Palmetto soybean oil sof...	21 Years -	Michigan State University

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