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Clinical Trial 17883
Cancer Type: Gynecological Tumor
Interventions:Fermented Wheat Germ Extract; Placebo
Study Type: Treatment
Phase of Study: Pilot
A Pilot Randomized, Placebo Controlled, Trial of Fermented Wheat Germ Extract in Women with Ovarian Cancer
The main purpose of this study is to test the safety, tolerability and quality of life in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE can be detected in the blood, and determine whether short-term therapy with FWGE has any effect on the tumor marker, cancer antigen 125 (CA-125).
2.21 Primary Objective: To assess the safety, toxicity and quality of life (QoL) of women with ovarian cancer scheduled to undergo surgery, administered FWGE versus placebo daily for 2 - 4 weeks. 2.22 Secondary Objectives: 2.221 To determine the level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) in the serum of women receiving FWGE versus placebo. 2.222 To estimate the impact of FWGE on: the tumor marker CA125, tumor proliferation. 2.23 Exploratory Objective: to determine the changes in gene expression in ovarian cancer exposed to FWGE versus placebo.