This early phase I trial studies the side effects of fermented wheat germ extract in treating patients with suspected ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery to help make a diagnosis. Fermented wheat germ extract has been shown in studies to stop the growth of cancer cells and inducing their death. Doctors also want to know whether patients taking the fermented wheat germ extract experience a positive or negative effect on quality of life. Giving fermented wheat germ extract before surgery may be safe and may improve quality of life by decreasing the symptoms associated with ovarian, fallopian tube, or peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02411565.
PRIMARY OBJECTIVES:
I. To assess the safety, toxicity and quality of life (QoL) of women with suspected ovarian cancer scheduled to undergo surgery, administered FWGE (fermented wheat germ extract) versus placebo daily for 2 - 4 weeks.
SECONDARY OBJECTIVES:
I. To develop pilot data on the impact of FWGE on: the tumor marker cancer antigen 125 (CA125), tumor proliferation.
II. To develop pilot data on changes in gene expression in ovarian cancer exposed to FWGE versus placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP I: Patients receive fermented wheat germ extract orally (PO) once daily (QD) for 2-4 weeks in the absence of unacceptable toxicity.
GROUP II: Patients receive placebo PO QD for 2-4 weeks in the absence of unacceptable toxicity.
In both arms, patients undergo surgery at 2-4 weeks. If surgery is delayed, patients may continue to receive fermented wheat germ extract or placebo until surgery for a period no greater than 2 months.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorHye Sook Chon
