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Fermented Wheat Germ Extract in Women With Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fermented Wheat Germ Extract (FWGE)
Placebo
Standard of Care: Planned Surgery
Quality of Life (QoL) Surveys: FACT-O
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring epithelial, ovarian, fallopian tube, primary peritoneal carcinoma, peritoneal, ovary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fermented Wheat Germ Extract (FWGE)

Placebo Administration

Arm Description

FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.

Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 3, 2015
Last Updated
January 15, 2019
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02411565
Brief Title
Fermented Wheat Germ Extract in Women With Ovarian Cancer
Official Title
A Pilot Randomized, Placebo-Controlled, Trial of Fermented Wheat Germ Extract in Women With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Drug manufacturing issues
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
January 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
epithelial, ovarian, fallopian tube, primary peritoneal carcinoma, peritoneal, ovary

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fermented Wheat Germ Extract (FWGE)
Arm Type
Active Comparator
Arm Description
FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
Arm Title
Placebo Administration
Arm Type
Placebo Comparator
Arm Description
Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
Intervention Type
Drug
Intervention Name(s)
Fermented Wheat Germ Extract (FWGE)
Other Intervention Name(s)
Avemar®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care: Planned Surgery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quality of Life (QoL) Surveys: FACT-O
Other Intervention Name(s)
questionnaire
Intervention Description
Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events Probably Related to Study Treatment
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Quality of Life Scores Per Treatment Arm
Description
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.
Time Frame
Up to 2 months
Title
Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)
Description
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.
Time Frame
Up to 2 months
Title
Occurence of CA-125 Response
Description
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.
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Incidence of Changes in Tissue Proliferative Assays and Gene Expression
Description
Changes in tissue proliferative assays and gene expression per treatment arm.
Time Frame
Up to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Sook Chon, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Fermented Wheat Germ Extract in Women With Ovarian Cancer

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