A Pilot Randomized, Placebo-Controlled, Trial of Fermented Wheat Germ Extract in Women With Ovarian Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse Events Probably Related to Study Treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fermented Wheat Germ Extract (FWGE)
FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
干预措施: Fermented Wheat Germ Extract (FWGE) (Drug)
Placebo Administration
Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of Adverse Events Probably Related to Study Treatment
时间窗: Up to 2 months
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.
次要结局
- Quality of Life Scores Per Treatment Arm(Up to 2 months)
- Occurence of CA-125 Response(Up to 2 months)
- Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)(Up to 2 months)