Esketamine hydrochloride for Oral mucositis

Inclusion criteria

• {"criterion_text":"- Are 18 years or older.\n- Receive high-dose chemotherapy in preparation for a stem cell transplant.\n- 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.\n- Can give written consent.\n- Speak and understand Dutch or English sufficiently to participate and to complete questionnaires."}

Exclusion criteria

• {"criterion_text":"- Are allergic to (es)ketamine or similar medicines.\n- Are simultaneously participating in another study that may interfere with this one.\n- Do not speak enough Dutch or English to participate.\n- Or if the doctor finds participation unsafe or unsuitable for you.\n- Have used (es)ketamine in the past 30 days.\n- Have (had) a psychosis or a severe, untreated psychiatric illness.\n- Have had problems with drug abuse or ketamine misuse.\n- Have severe liver problems or an unstable heart condition.\n- Have increased intracranial pressure.\n- Have an untreated infection in the mouth or throat.\n- Cannot safely use mouthwash (for example, due to swallowing problems or drowsiness).\n- Are pregnant or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pain measured using Numerical Rating Scale (NRS) for oral and pharyngeal pain at 1 hour after first dose; non-inferiority assessed by two-sided 95% CI for difference (mouthwash – IV) with non-inferiority margin upper bound < 1.3 NRS points."}

Secondary endpoints

• {"endpoint_text":"- Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), graded using CTCAE v5.0, during the treatment period.","definition_or_measurement_approach":"AEs and SAEs collected during treatment and graded using CTCAE v5.0."}
• {"endpoint_text":"- Change in average oral and pharyngeal pain score (NRS) from baseline to end of treatment.","definition_or_measurement_approach":"Difference in NRS pain scores comparing baseline to end of treatment."}
• {"endpoint_text":"- Daily assessment of oral intake and use of tube feeding or parenteral nutrition, summarized at end of treatment.","definition_or_measurement_approach":"Daily records of oral intake and any use of enteral/parenteral nutrition, summarized at treatment end."}
• {"endpoint_text":"- Scores on the Daily Oral Mucositis Questionnaire (DOMQ), assessed daily and summarized at end of treatment.","definition_or_measurement_approach":"Daily DOMQ scores collected and summarized at end of treatment."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported daily 4-point Likert-scale questionnaire for local and systemic side effects; clinical staff recordings complement patient reports."}
• {"endpoint_text":"- Total morphine-equivalent dose administered during the treatment period.","definition_or_measurement_approach":"Cumulative morphine-equivalent opioid dose administered during treatment period."}
• {"endpoint_text":"- Total number of hospital days from randomization to discharge.","definition_or_measurement_approach":"Count of hospital days between randomization and discharge."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Records of days treated, missed doses/pauses, and documentation of early terminations with reasons."}
• {"endpoint_text":"- Plasma concentrations of esketamine and norketamine at predefined time points, analyzed to assess systemic exposure and metabolism for each administration route.","definition_or_measurement_approach":"Pharmacokinetic sampling at predefined time points measuring plasma esketamine and norketamine concentrations to assess systemic exposure and metabolism per route."}

Netherlands

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

8

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands