Fermented Wheat Germ Extract in Women With Ovarian Cancer

NCT ID: NCT02411565

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2018-01-08

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).

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fermented Wheat Germ Extract (FWGE)

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

Group Type: ACTIVE_COMPARATOR

Fermented Wheat Germ Extract (FWGE)

Intervention Type: DRUG

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.

Standard of Care: Planned Surgery

Intervention Type: OTHER

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.

Quality of Life (QoL) Surveys: FACT-O

Intervention Type: OTHER

Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.

Placebo Administration

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Standard of Care: Planned Surgery

Intervention Type: OTHER

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.

Quality of Life (QoL) Surveys: FACT-O

Intervention Type: OTHER

Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Avemar®; questionnaire

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hye Sook Chon, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MCC-17883

Identifier Type: -

Identifier Source: org_study_id