A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
研究概览
简要总结
The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.
详细描述
Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven squamous cell carcinoma of the head and neck (SCCHN)
- •Primary disease site involving the oropharynx
- •Clinical stage III or IV
- •Karnofsky Performance Status (KPS) ≥ 70
- •Adequate bone marrow, kidney, and hepatic function (no laboratory value > 2 times the normal limit)
- •Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal
排除标准
- •Prior history of SCCHN
- •Prior history of radiation to the head and neck region
- •KPS < 70
- •Soy allergy
- •Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy
- •Any head and neck cancer of non-squamous histology
- •Any head and neck subsite other than oropharynx (including unknown primary site)
- •Patients who are pregnant or lactating
- •Patients who may benefit from surgical resection
研究组 & 干预措施
Soy isoflavone
Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin
干预措施: Soy isoflavone (Drug)
Soy isoflavone
Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin
干预措施: Radiation (Radiation)
Soy isoflavone
Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
时间窗: 1 year after treatment completion
The primary outcome of this study is the percentage of patients with symptomatic (grade 2 or higher) xerostomia at 1 year post-treatment, assessed by the Late Effects of Normal Tissues (LENT)/Subjective, Objective, Management, Analytic (SOMA) method.
次要结局
- Exploratory biomarker studies: changes in interleukin 6(3 and 6 months post-treatment)
- Exploratory biomarker studies: changes in vascular endothelial growth factor(3 and 6 months post-treatment)
- Exploratory biomarker studies: changes in isoprostanes levels(3 and 6 months post-treatment)
研究者
Kristin Higgins, MD
Principal Investigator
Emory University