Clinical trial NCT02411565: Fermented Wheat Germ Extract in Women With Ovarian Cancer
Official title: A Pilot Randomized, Placebo-Controlled, Trial of Fermented Wheat Germ Extract in Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Ovarian Cancer
Keywords: epithelial
ovarian
fallopian tube
primary peritoneal carcinoma
peritoneal
ovary
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Occurrence of Adverse Events Probably Related to Study Treatment
timeFrame: Up to 2 months
Secondary outcomes:
measure: Quality of Life Scores Per Treatment Arm
timeFrame: Up to 2 months
measure: Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)
timeFrame: Up to 2 months
measure: Occurence of CA-125 Response
timeFrame: Up to 2 months
Other outcomes:
measure: Incidence of Changes in Tissue Proliferative Assays and Gene Expression
timeFrame: Up to 2 months
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Hye Sook Chon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: