scholarly journals Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

2017 ◽  
Vol 89 (3) ◽  
pp. 197 ◽  
Author(s):  
Salvatore Micali ◽  
Angelo Territo ◽  
Giacomo Maria Pirola ◽  
Nancy Ferrari ◽  
Maria Chiara Sighinolfi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Green Tea ◽  
Phase Ii ◽  
Intraepithelial Neoplasia ◽  
Phase Ii Clinical Trial ◽  
High Grade ◽  
Double Blind ◽  
Tea Catechins ◽  
Study Objective ◽  
Green Tea Catechins

Background and study objective: Several studies suggest a protective role of green tea catechins against prostate cancer (PCa). In order to evaluate the efficacy of green tea catechins for chemoprevention of PCa in patients with high-grade prostate intraepithelial neoplasia (HG-PIN) we performed a phase II clinical trial. Methods: Sixty volunteers with HG-PIN were enrolled to carry out a double-blind randomized placebo-controlled phase II clinical trial. Treated group took daily 600 mg of green tea catechins (Categ Plus®) for 1 year. Patients were screened at 6 and 12 months through prostatic biopsy and measurements of prostate-specific antigen (PSA). Results: Despite the statistically significant reduction of PSA observed in subjects who received green tea catechins for 6 and 12 months, we did not find any statistical difference in PCa incidence between the experimental groups neither after 6 nor after 12 months. However, throughout the one-year follow- up we observed very limited adverse effects induced by green tea catechins and a not significant improvement in lower urinary tract symptoms and quality of life. Conclusions: Although the small number of patients enrolled in our study and the relatively short duration of intervention, our findings seems to deny the efficacy of green tea catechins. However, results of our clinical study, mainly for its low statistical strength, suggest that the effectiveness of green tea catechins should be evaluated in both a larger cohort of men and longer trial.

scholarly journals AT-46 * VORINOSTAT AND BEVACIZUMAB FOR RECURRENT HIGH-GRADE GLIOMA: INTERIM ANALYSIS OF A PHASE II CLINICAL TRIAL

2014 ◽  
Vol 16 (suppl 5) ◽  
pp. v18-v18
Author(s):  
K. Peters ◽  
D. Reardon ◽  
D. Randazzo ◽  
S. Dutton ◽  
A. Edwards ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Interim Analysis ◽  
High Grade Glioma ◽  
Phase Ii Clinical Trial ◽  
High Grade

scholarly journals The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-11
Author(s):  
Xuemei Liu ◽  
Juanjuan Fu ◽  
Tao Fan ◽  
Wei Liu ◽  
Hongli Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Study Protocol ◽  
Common Cold ◽  
Dose Group ◽  
Deficiency Syndrome ◽  
Phase Ii Clinical Trial ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design. This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson’s scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson’s scale and TCM symptom scale. Ethics and Trial Registration. This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).

scholarly journals CHEMOPREVENTION OF HUMAN PROSTATE CANCER BY ORAL ADMINISTRATION OF GREEN TEA CATECHINS: A TRANSLATIONAL RESEARCH STORY

2008 ◽  
Vol 65 (1) ◽  
Author(s):  
S Bettuzzi ◽  
F Rizzi
Keyword(s):  
Prostate Cancer ◽  
Green Tea ◽  
Cell Transformation ◽  
Treatment Options ◽  
Intraepithelial Neoplasia ◽  
Clinical Progression ◽  
Elderly Men ◽  
Tea Catechins ◽  
Green Tea Catechins ◽  
Tumour Activity

Clinical progression of Prostate Cancer (CaP) is variable: some tumours are indolent, others rapidly progress. Because, diagnosis is usually in elderly men, CaP is an ideal target for chemoprevention. We showed that Green Tea Catechins (GTC) possess anti-tumour activity, suggesting that it might be beneficial in the early stages of cell transformation. But an experimental confirmation in a real clinical setting was needed. High-Grade Prostatic Intraepithelial Neoplasia (HGPIN) is a pre-invasive stage of CaP for which no treatment options are available until CaP is diagnosed.

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