A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 120
- 主要终点
- Total Pain Reduction (Mouth and Throat)
研究概览
简要总结
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.
详细描述
OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on day 1.
Patients may crossover to arm I on day 2. The primary and secondary objectives are detailed below.
Primary Objective:
Determine whether doxepin oral rinse is effective in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at 5,15, 30, 60, 120 and 240 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •≥ 18 years of age
- •Histologic proof of malignancy currently undergoing a course of RT (with or without chemotherapy) to a dose of ≥ 5000 cGy using 1.60 to 2.20 Gy per fraction. Note: At least one third of the oral cavity mucosa must be included in the radiation therapy fields.
- •≥ 4 oral pain felt to be related to mucositis for which the patient wants relief as measured by the Numeric Measure of Oral Pain. Note: An oral exam confirming the presence of mucositis should be performed by the enrolling clinician in addition to patient feedback.
- •Ability to complete questionnaire(s) independently or with assistance
- •ECOG Performance Status 0, 1 or
- •Provide informed written consent.
- •Willingness to return to enrolling institution for follow-up.
排除标准
- •Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation
- •Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration
- •Current untreated or unresolved oral candidiasis or oral HSV infection
- •Current untreated narrow angle glaucoma
- •Current untreated urinary retention ≤ 6 weeks prior to registration
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Any of the following because this study involves a study agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
研究组 & 干预措施
Arm I
Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
干预措施: doxepin hydrochloride (Drug)
Arm II
Patients receive placebo oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
干预措施: placebo (Other)
结局指标
主要结局
Total Pain Reduction (Mouth and Throat)
时间窗: Baseline and Day 1
The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.
次要结局
- Total Taste of the Oral Rinse(Up to 9 days)
- Total Stinging or Burning From the Oral Rinse(Up to 9 days)
- Total Drowsiness Increase(Up to 9 days)
- Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash(Up to 9 days)
- Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride(Up to 9 days)