Clinical Trial 17883

Cancer Type: Gynecological Tumor
Interventions:Fermented Wheat Germ Extract; Placebo

Study Type: Treatment
Phase of Study: Pilot
Investigators:


    Overview

    Study Title

    A Pilot Randomized, Placebo Controlled, Trial of Fermented Wheat Germ Extract in Women with Ovarian Cancer

    Summary

    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).

    Objective

    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.

    Inclusion Criteria

  • Women with suspected epithelial ovarian, fallopian tube or primary peritoneal carcinoma scheduled to undergo surgical exploration with no prior treatment for the cancer. Signs of ovarian cancer include, but are not limited to: an elevated cancer antigen 125 (CA-125), a complex pelvic mass, ascites, and carcinomatosis. These signs are not necessary for suspicion or enrollment in this protocol.
  • Age > 18 years and competent to give informed consent.
  • Must have a Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 and a life-expectancy of at least 60 days.
  • Adequate bone marrow function.
  • Adequate renal function.
  • Adequate hepatic function.
  • Participants must sign an approved informed consent and authorization permitting release of personal health information.
  • Women of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.

  • Exclusion Criteria

  • Current use of Fermented Wheat Germ Extract (FWGE).
  • Known allergy to wheat, rice (contained in the placebo), orange or the sweetener, Stevia.
  • Potential participants who received neoadjuvant chemotherapy for ovarian cancer.
  • An upper gastrointestinal or other condition that would impair swallowing or absorption of oral medication.
  • Any serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not to limited, any the following: History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychiatric disorders) that would impair the ability to obtain consent or limit compliance with study requirement; Active uncontrolled or serious infection; Active peptic ulcer disease.
  • Uncontrolled hypertension defined as systolic greater than 180 and diastolic greater than 100.