NCT02411565

Fermented Wheat Germ Extract in Women With Ovarian Cancer

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-15
• Completion: 2018-01-08
• First posted: 2015-04-08
• Last updated: 2019-01-23
• Results posted: 2019-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study