The main purpose of this Pilot 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).
- 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.
- Current use of FWGE
- Known allergy to wheat, rice (contained in the placebo), orange or the sweetener,
- 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