Evaluation and Treatment of Reflux Disease in Patients With Head and Neck Cancer Undergoing Radiation Therapy That Causes Significant Mucositis in the Reflux Field and Xerostomia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Frequency of acid reflux episode (during each 24 hour pH probe)
研究概览
简要总结
The goal of this clinical research study is to learn if radiation-induced xerostomia [RIX] (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like symptoms) in head and neck cancer (HNC) patients receiving radiation therapy.
Objectives:
Primary Objective:
Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6-12 weeks after RT (measured by # episodes, their duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the curve for all episodes of pH<4 recorded during the study in units of Ph*minutes. The Reflux area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).
Secondary Objectives:
- To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
- Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to determine if radiation induced hyposalivation is associated with more reflux events and symptoms.
- For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion to acid-positive reflux measured approximately 6-12 weeks after RT.
- Correlate office indirect laryngoscopy findings (posterior commissure thickening, cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)
- Compare findings from the patient reported outcome (PRO) instruments used
详细描述
The Study Drug:
Dexlansoprazole is designed to block the production of excess stomach acid that is the cause of acid reflux disease.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 groups, based on the results of your screening tests.
If you are assigned to Group 1, you will not receive any study drug, but you will complete the study visits and radiation therapy, as described below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed informed consent.
- •Head and neck cancer (HNC) Oropharynx cancer (OPC) patients who are adults > 18 years of age, dispositioned to receive curative RT with bilateral neck (including) parotid irradiation with or without chemotherapy.
- •Radiation Therapy (3D conformal or IMRT).
排除标准
- •Subjects unable to tolerate pH-probe in past.
- •Subjects currently on proton-pump inhibitor (PPI), daily antacids and daily H2 antagonists.
- •Prior history of esophago-gastric surgery.
- •Symptoms of active gastrointestinal bleeding (melena, hematemesis).
- •Known hepatic cirrhosis or esophageal varices.
- •Prior esophageal perforation.
- •Pregnant or lactating woman. Women of childbearing potential who have not undergone a hysterectomy with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable and appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- •Subjects with allergies or sensitivities to proton-pump inhibitors.
- •Patients who cannot complete study follow-up and compliance with study protocol.
- •Patients on Plavix (if medically appropriate)
研究组 & 干预措施
Group 2
Patients with acid reflux.
干预措施: Dexlansoprazole (Drug)
结局指标
主要结局
Frequency of acid reflux episode (during each 24 hour pH probe)
时间窗: Before radiotherapy and again at 6 weeks following radiotherapy
次要结局
未报告次要终点