2025-522545-22-00招募中2 期
Comparison of esketamine mouthwash versus intravenous administration for the treatment of chemotherapy/radiotherapy-induced mucositis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average oral and pharyngeal pain score (Numerical Rating Scale, NRS) at 1-hour post-first dose, compared between treatment arms to assess non-inferiority. Esketamine mouthwash will be declared non-inferior if the upper bound of the two-sided 95% confidence interval for the difference (mouthwash – IV) is < 1.3 NRS points.
研究概览
简要总结
To evaluate the non-inferiority of esketamine mouthwash compared to intravenous esketamine in reducing mucositis-related pain in patients undergoing hematopoietic stem cell transplantation.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Are 18 years or older.
- •Receive high-dose chemotherapy in preparation for a stem cell transplant.
- •Develop painful mouth or throat pain (oral mucositis WHO ≥ 2) during admission that are not relieved by regular painkillers. To determine this, the researchers and/or doctors will examine your mouth.
- •Can give written consent.
- •Speak and understand Dutch or English sufficiently to participate and to complete questionnaires.
排除标准
- •Are allergic to (es)ketamine or similar medicines.
- •Are simultaneously participating in another study that may interfere with this one.
- •Do not speak enough Dutch or English to participate.
- •Or if the doctor finds participation unsafe or unsuitable for you.
- •Have used (es)ketamine in the past 30 days.
- •Have (had) a psychosis or a severe, untreated psychiatric illness.
- •Have had problems with drug abuse or ketamine misuse.
- •Have severe liver problems or an unstable heart condition.
- •Have increased intracranial pressure.
- •Have an untreated infection in the mouth or throat.
- •Cannot safely use mouthwash (for example, due to swallowing problems or drowsiness).
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Esketamine HCl (Mouthwash)
Test
干预措施: Esketamine HCl (Mouthwash) (Drug)
Esketamine Orifarm 5 mg/ml injektions-/infusionsvätska, lösning
Comparator
干预措施: Esketamine Orifarm 5 mg/ml injektions-/infusionsvätska, lösning (Drug)
结局指标
主要结局
Average oral and pharyngeal pain score (Numerical Rating Scale, NRS) at 1-hour post-first dose, compared between treatment arms to assess non-inferiority. Esketamine mouthwash will be declared non-inferior if the upper bound of the two-sided 95% confidence interval for the difference (mouthwash – IV) is < 1.3 NRS points.
Average oral and pharyngeal pain score (Numerical Rating Scale, NRS) at 1-hour post-first dose, compared between treatment arms to assess non-inferiority. Esketamine mouthwash will be declared non-inferior if the upper bound of the two-sided 95% confidence interval for the difference (mouthwash – IV) is < 1.3 NRS points.
次要结局
- Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), graded using CTCAE v5.0, during the treatment period.
- Change in average oral and pharyngeal pain score (NRS) from baseline to end of treatment.
- Daily assessment of oral intake and use of tube feeding or parenteral nutrition, summarized at end of treatment.
- Scores on the Daily Oral Mucositis Questionnaire (DOMQ), assessed daily and summarized at end of treatment.
- Frequency, severity, and type of local and systemic side effects, as reported by patients using a standardized 4-point Likert-scale questionnaire, completed daily during the treatment period. Clinical staff will also record any observed side effects.
- Total morphine-equivalent dose administered during the treatment period.
- Total number of hospital days from randomization to discharge.
- Total number of treatment days completed (length of treatment), number of missed doses or pauses (breaks in treatment), and documentation of early termination or discontinuation including reasons.
- Plasma concentrations of esketamine and norketamine at predefined time points, analyzed to assess systemic exposure and metabolism for each administration route.
研究者
Saskia T. M. Ammer
Scientific
Amsterdam UMC Stichting
研究点 (1)
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