Efficacy of FWGE in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients
Recruitment status was: Recruiting
We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line hormone therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective. The study will be conducted during two years with 60 patients. The efficacy will be assessed in terms of clinical and serological response and by specific questionnaires.
This concept is based on previous reports regarding other diseases such as colon cancer, where the addition of a new drug to a drug which previously had failed, improved the patients' survival, the quality of life and the clinical parameters. In addition, preclinical data have shown activity of that regimen in prostate cancer cell lines and in animals' models.
FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It increased the natural immune responses while decreasing the systemic inflammation often present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice and prolonged their survival. It delayed disease progression, increased overall survivals, improve quality of life and reduce oxidative stress.
The long-term goal of this research is that the addition of FWGE to a drug which previously had failed, would slow down disease progression in patients with advanced and thus refractory cancers, improving the patients' quality of life, their clinical parameters and survival.
|Hormone Refractory Prostate Cancer||Drug: Fermented Wheat germ extract||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Phase II Clinical Trial of Fermented Wheat Germ Extract in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients|
- Response rate in 16 weeks. [ Time Frame: 1 year ]
- Quality of life in 16 weeks [ Time Frame: 1 year ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Fermented Wheat germ extract
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411853
|Contact: Nava Epstein, PhDemail@example.com|
|Contact: Rony Weitzen, MD||972-3-530-2997|
|Oncology Division Sheba Medical Center||Recruiting|
|Tel Hashomer, Ramat Gan, Israel, 52621|
|Contact: Rony Weitzen, MD|
|Principal Investigator:||Rony Weitzen, MD||Oncology Division Sheba Medical Center|