Fermented Wheat Germ Extract in Women With Ovarian Cancer

NCT02411565 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: MCC-17883
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

epithelial; ovarian; fallopian tube; primary peritoneal carcinoma; peritoneal; ovary

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 months

Secondary Outcomes (3)

• Quality of Life Scores Per Treatment Arm

  Up to 2 months

• Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)

  Up to 2 months

• Occurence of CA-125 Response

  Up to 2 months

Other Outcomes (1)

• Incidence of Changes in Tissue Proliferative Assays and Gene Expression

  Up to 2 months

Study Arms (2)

Fermented Wheat Germ Extract (FWGE)

ACTIVE COMPARATOR

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

Drug: Fermented Wheat Germ Extract (FWGE); Other: Standard of Care: Planned Surgery; Other: Quality of Life (QoL) Surveys: FACT-O

Placebo Administration

PLACEBO COMPARATOR

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

Drug: Placebo; Other: Standard of Care: Planned Surgery; Other: Quality of Life (QoL) Surveys: FACT-O

Interventions

Fermented Wheat Germ Extract (FWGE) 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.

Also known as: Avemar®

Fermented Wheat Germ Extract (FWGE)

Placebo 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.

Placebo Administration

Standard of Care: Planned Surgery 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.

Fermented Wheat Germ Extract (FWGE); Placebo Administration

Quality of Life (QoL) Surveys: FACT-O OTHER

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

Also known as: questionnaire

Fermented Wheat Germ Extract (FWGE); Placebo Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Avemar; Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Hye Sook Chon
• Organization: H. Lee Moffitt Cancer Center and Research Institute

hyesook.chon@moffitt.org

813-745-7205

Study Officials

• Hye Sook Chon, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2016
• Primary Completion: December 15, 2017
• Study Completion: January 8, 2018
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2018-04

Locations

US (1)