Fermented Wheat Germ Extract in Women With Ovarian Cancer

January 15, 2019 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fermented Wheat Germ Extract (FWGE)
FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
Drug: Fermented Wheat Germ Extract (FWGE)
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.
Other Names:
  • Avemar®
Other: Standard of Care: Planned Surgery
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.
Other: Quality of Life (QoL) Surveys: FACT-O
Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.
Other Names:
  • questionnaire
Placebo Comparator: Placebo Administration
Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
Other: Standard of Care: Planned Surgery
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.
Other: Quality of Life (QoL) Surveys: FACT-O
Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.
Other Names:
  • questionnaire
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Changes in Tissue Proliferative Assays and Gene Expression
Time Frame: Up to 2 months
Changes in tissue proliferative assays and gene expression per treatment arm.
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Hye Sook Chon, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-17883

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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