A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)
研究概览
简要总结
This pilot randomized phase II trial studies who well chlorine dioxide sterilization works in reducing oral mucositis in patients with stage I-IV head and neck cancer who are undergoing radiotherapy. Chlorine dioxide sterilization may help to treat oral mucositis.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the incidence of severe oral oral mucositis (OM) (>= World Health Organization [WHO] grade 3).
SECONDARY OBJECTIVES:
I. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the time to onset of severe OM (>= WHO grade 3).
II. To evaluate and compare CloSYS Unflavored Oral Rinse effect on the duration of severe OM (>= WHO grade 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Able to provide properly obtained written informed consent
- •Pathologically-confirmed diagnosis of head and neck malignancy (stage I-IV)
- •Planned to receive high dose RT >= 50 gray (Gy) to visualizable oral cavity and/or oropharyngeal mucosa, with or without administration of concurrent systemic therapy
- •Karnofsky performance status of >= 60, within 45 days of registration
- •Hematocrit (Hct) > 20 within 90 days of registration to the study
- •Normal cognition and willingness to complete OMWQ and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTAE) forms at each designated time point along with oral rinse diary
- •Life expectancy >= 3 months
- •Willing to tolerate oral rinsing for 30 second intervals
- •Negative serum pregnancy test in females of childbearing age
- •Must be willing to use an effective form of birth control if of child bearing potential
排除标准
- •Known hypersensitivity to chlorine dioxide products
- •Chlorine dioxide product usage within the past 7 days prior to registration for this study
- •Utilization of any antibiotic medications (topical or systemic) within past 7 days prior to registration for this study
- •Utilization of daily anti-inflammatory or corticosteroid medication (topical or systemic) for chronic indication other than daily low dose aspirin (81 mg)
- •Sjogrens disease
- •Medically documented glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Baseline hematocrit =< 20%
- •Planned daily RT of less than 5 weeks duration
- •Known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •Current pregnancy
研究组 & 干预措施
Arm I (chlorine dioxide sterilization)
Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.
干预措施: Chlorine Dioxide Sterilization (Drug)
Arm I (chlorine dioxide sterilization)
Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)
时间窗: Up to 30 days post radiotherapy
Will be compared between arms. Analysis will be performed by estimating the proportion with exact 95% binomial confidence interval for each group separately. Statistical testing will use a chi-square test. As an alternative, Fisher?s Exact Test will be used if the minimum expected value is \< 5. WHO Scale: Grade 0 (none) - None; Grade I (mild) - Oral soreness, erythema; Grade II (moderate) - Oral erythema, ulcers, solid diet tolerated; Grade III (severe) - Oral ulcers, liquid diet only; Grade IV (life-threatening) - Oral alimentation impossible. No grade 3 or higher Oral Mucositis was reported on either treatment arm, so no differences were observed.
次要结局
- Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)(Up to 30 days post radiotherapy)
- Time to Onset of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)(Up to 30 days post radiotherapy)
- Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)(Up to 30 days post radiotherapy)
- Rates of Radiotherapy Interruption(Up to 30 days post radiotherapy)