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Efficacy of FWGE in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients

NCT00411853 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Hormone Refractory Prostate Cancer

Interventions

DRUG

Fermented Wheat germ extract

Fermented Wheat Germ powder, given orally, per os, 17 gram daily

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Rony Weitzen, MD · Oncology Division Sheba Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00411853 on ClinicalTrials.gov