Saw Palmetto: Symptom Management for Men During Radiation Therapy
关键词
抽象
描述
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.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 04/22/2012 |
| 提交的预估入学人数: | 04/22/2012 |
| 首次发布: | 04/24/2012 |
| 上次提交的更新: | 09/25/2019 |
| 最近更新发布: | 09/29/2019 |
| 首次提交结果的日期: | 05/03/2016 |
| 首次提交质量检查结果的日期: | 06/15/2017 |
| 首次发布结果的日期: | 07/13/2017 |
| 实际学习开始日期: | 09/30/2011 |
| 预计主要完成日期: | 03/31/2015 |
| 预计完成日期: | 03/31/2015 |
状况或疾病
干预/治疗
Drug: Saw Palmetto
Drug: Phase 2: RCT phase- Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: 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 | |
| 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. | |
| Placebo Comparator: Phase 2: RCT phase- Placebo Patients received Soybean Oil Soft Gel as the placebo treatment | Drug: Phase 2: RCT phase- Placebo placebo (soybean oil soft gel) |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | Male |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age 21 years or older - Adenocarcinoma of the prostate - Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml - Combined Gleason Score ≤ 8 - Karnofsky level of performance of > 70% - Consented to undergo definitive Radiation Therapy Exclusion Criteria: - Stage T4 or M1 - Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen). - Prior pelvic radiation therapy - Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase. - Uncontrolled hypertension despite use of antihypertensive medication - Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months) |
结果
主要结果指标
1. Feasibility [Baseline to Week 12 for each phase.]
2. Efficacy [HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.]
3. Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose [Baseline to Week 12]
