Fermented Wheat Germ Extract in Women With Ovarian Cancer

Study Overview
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Brief Summary
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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).

Official Title
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A Pilot Randomized, Placebo-Controlled, Trial of Fermented Wheat Germ Extract in Women With Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Fermented Wheat Germ Extract (FWGE)
* Drug: Placebo
* Other: Standard of Care: Planned Surgery
* Other: Quality of Life (QoL) Surveys: FACT-O


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fermented Wheat Germ Extract (FWGE)<br>FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O. | Drug: Fermented Wheat Germ Extract (FWGE)<br>* 5.53 grams of FWGE combined with natural orange flavor and stevia Reb-A sweetener to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks.<br>* Other names: Avemar®;Other: Standard of Care: Planned Surgery<br>* Participants will undergo their planned surgery during the 2nd to 4th week after entry into the study. However, if there are delays, patients can continue to take drug/placebo for a time period no greater than 2 months. If surgery has not occurred after this 2-month period, the patient will be removed from the study. Participants will take the study drug up until the day prior to surgery. The minimum amount of time on study drug is 2 weeks. A separate consent form will be obtained for the surgical procedure.<br>Other: Quality of Life (QoL) Surveys: FACT-O<br>* Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.<br>* Other names: questionnaire;|
| Placebo Comparator: Placebo Administration<br>Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O. | Drug: Placebo<br>* Dried and pulverized, white and black rice, 5.53 grams, combined with natural orange flavor and stevia Reb-A sweetener, to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks.<br>Other: Standard of Care: Planned Surgery<br>* Participants will undergo their planned surgery during the 2nd to 4th week after entry into the study. However, if there are delays, patients can continue to take drug/placebo for a time period no greater than 2 months. If surgery has not occurred after this 2-month period, the patient will be removed from the study. Participants will take the study drug up until the day prior to surgery. The minimum amount of time on study drug is 2 weeks. A separate consent form will be obtained for the surgical procedure.<br>Other: Quality of Life (QoL) Surveys: FACT-O<br>* Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.<br>* Other names: questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events Probably Related to Study Treatment | 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. | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Scores Per Treatment Arm | 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. | Up to 2 months | 
| Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) | 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. | Up to 2 months | 
| Occurence of CA-125 Response | 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. | Up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epithelial, ovarian, fallopian tube, primary peritoneal carcinoma, peritoneal, ovary