A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
研究概览
简要总结
This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.
详细描述
PRIMARY OBJECTIVES:
I. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16, cyclooxygenase 2 [COX-2], vascular endothelial growth factor receptor [VEGF], epidermal growth factor receptor [EGFR], interleukin-6 [IL6], p53 and B-cell lymphoma-extra large [Bcl-xL] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous carcinoma undergoing curative tumor resection.
II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.
SECONDARY OBJECTIVES:
I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- •Disease must be Stage I, II, III or IVa
- •Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Patients must give documented informed consent to participate in this study
排除标准
- •Documented evidence of distant metastases
- •Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
- •Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
- •A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
- •Patients residing in prison
- •Any patient with a history of breast or ovarian cancer
- •Allergy to soy products
研究组 & 干预措施
Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
干预措施: Soy Isoflavones (Drug)
Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
干预措施: Survey Administration (Other)
结局指标
主要结局
Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
时间窗: From baseline to surgery, up to 42 days
The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.
Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
时间窗: Up to 12 months
Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.
次要结局
- The Number of Participants Alive at Follow-up(Up to 24 months)
- The Number of Participants Alive Without Relapse at Last Follow-up(Up to 24 months)