Fermented Wheat Germ Extract in Women With Ovarian Cancer

Early Phase 1

Terminated

Brief Summary: 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).

Recruitment & Eligibility

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 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.

Arm && Interventions

Group	Intervention	Description
Fermented Wheat Germ Extract (FWGE)	Fermented Wheat Germ Extract (FWGE)	FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
Placebo Administration	Placebo	Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events Probably Related to Study Treatment	Up to 2 months	Adverse events reported per treatment arm. An adverse event is the development of an untoward medical occurrence, undesirable medical condition, or recurrence or deterioration of a pre-existing medical condition subsequent to exposure to FWGE. This study will utilize the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for toxicity and adverse event reporting. Number of Adverse Events Probably Related to Study Treatment. All Adverse Events are listed, with causality noted in the Adverse Event section.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Scores Per Treatment Arm	Up to 2 months	FACT-O Quality of Life Score comparison per category and arm: Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Additional Concerns. Score range for each question: 0 (Not at all) through 4 (Very much). High or Low Score could mean better or worse, depending on the wording of each group of questions. Investigators planned to analyze scores per treatment arm, in women who received Fermented Wheat Germ Extract (FWGE) (n=10) and those who received placebo (n=10). Drug manufacturing issues prevented investigators from completing the planned analysis.
Occurence of CA-125 Response	Up to 2 months	Biomarker-based response involves assessing the participant's longitudinal CA-125 values. The definition of CA-125 response is based on the Gynecologic Cancer Intergroup (GCIG 2005) criteria. CA-125 response was to be determined and compared between FWGE and placebo treated groups of 10 participants each.
Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)	Up to 2 months	Investigators planned to perform Level comparison of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) in the serum of women receiving FWGE versus placebo for 20 participants.