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Fermented Wheat Germ Extract in Women With Ovarian Cancer

NCT02411565 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-01-23

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-12-15
Completion
2018-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411565 on ClinicalTrials.gov