Saw Palmetto: Symptom Management for Men During Radiation Therapy
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 08/31/2019 |
| İlk Gönderilen: | 04/22/2012 |
| Tahmini Kayıt Gönderildi: | 04/22/2012 |
| İlk Gönderilen: | 04/24/2012 |
| Son Güncelleme Gönderildi: | 09/25/2019 |
| Son Güncelleme Gönderildi: | 09/29/2019 |
| İlk gönderilen sonuçların tarihi: | 05/03/2016 |
| QC sonuçlarının ilk gönderildiği tarih: | 06/15/2017 |
| İlk yayınlanan sonuçların tarihi: | 07/13/2017 |
| Fiili Çalışma Başlangıç Tarihi: | 09/30/2011 |
| Tahmini Birincil Tamamlanma Tarihi: | 03/31/2015 |
| Tahmini Çalışma Tamamlanma Tarihi: | 03/31/2015 |
Durum veya hastalık
Müdahale / tedavi
Drug: Saw Palmetto
Drug: Phase 2: RCT phase- Placebo
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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) |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 21 Years İçin 21 Years |
| Çalışmaya Uygun Cinsiyetler | Male |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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) |
Sonuç
Birincil Sonuç Ölçütleri
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]
