Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Other Dietary Supplements

Orange

Stevia

Stevioside

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.

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.

Fermented Wheat Germ Extract (FWGE)

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.

Placebo

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.

Standard of Care: Planned Surgery

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

Quality of Life (QoL) Surveys: FACT-O

Hye Sook Chon, M.D.

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).

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

Changes in tissue proliferative assays and gene expression per treatment arm.

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.

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.

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.

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.

H. Lee Moffitt Cancer Center and Research Institute

FWGE administration 2 - 4 weeks prior to planned surgery.

Placebo administration 2 - 4 weeks prior to planned surgery.

Placebo Administration

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

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Accrual was closed prematurely due to drug manufacturing issues and slow enrollment. Outcome Measures were designed for 20 participants, to complete a comparison of 2 study arms with 10 participants each.

Dr. Hye Sook Chon

Occurrence of Adverse Events Probably Related to Study Treatment

Drug manufacturing issues prevented investigators from completing the planned analysis.

Spots Global Cancer Trial Database for Fermented Wheat Germ Extract in Women With Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial