Clinical trial · Interventional
NAC to Prevent Cisplatin-induced Hearing Loss
A Dose-Finding Study of N-Acetylcysteine (NAC) to Prevent Cisplatin-induced Hearing Loss in Children With Cancer
NCT02094625CI-TRIAL-00065736completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to determine the dose necessary to protect hearing and also how well tolerated NAC is when combined with chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroectodermal Tumors, Primitive | Primitive Neuroectodermal Tumor | ONTOLOGY_EXACT | 0.98 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Other Childhood Cancers Using Cisplatin-based Regimens | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-Acetylcysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- N-Acetylcysteine Intervention
- description
- This is a dose-finding study using a traditional 3+3 dose escalation scheme. Up to 18 subjects (3 dose levels as per below) will be enrolled to determine the maximum tolerated dose (MTD). The MTD is defined as per traditional 3+3 criteria of less than or equal to one dose-limiting toxicity at the dose level. Once the MTD is determined, subjects will be equally distributed at the "safe" dose levels (less than or equal to the MTD) to determine the optimum dose to achieve NAC levels in the blood necessary for hearing protection. As of August 2018: The dose-escalation phase was completed and dose-level three was selected for expansion in 9 subjects.
- interventionNames
- Drug: N-Acetylcysteine
- type
- NO_INTERVENTION
- label
- Observation only
- description
- Subjects who are ineligible to receive the study drug NAC will have the option to enroll for study assessments only including laboratory testing and hearing assessments identical to the experimental intervention arm. This is a "cohort of convenience" for which we anticipate up to 36 children will be enrolled over the course of the study.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Are between 1 and 21 years of age (inclusive) at time of diagnosis of underlying malignancy * Have a new diagnosis of a localized malignancy with a planned treatment course to include at least two cycles of cisplatin * Diagnosis to be assigned by oncology attending of record (may be reported via designee), histological diagnosis does not need to be confirmed separately * Most common but not exclusive diagnoses consist of hepatoblastoma, medulloblastoma, osteosarcoma * Total cumulative dose of planned cisplatin must be \>200 mg/m2 (or 6.67 mg/kg equivalent for infants requiring weight-based dosing. Conversion factor used is 30:1). * Cisplatin must be delivered over \<3 days * Planned cisplatin dose to be infused over ≤6 hours for ≤2 days per cycle * Are anticipated to be able to comply with end-of-therapy audiology assessment (note that hearing assessments are performed per routine clinical care in children receiving cisplatin and consist of an audiogram or auditory brainstem response, and distortion-product otoacoustic emissions) * Patients with any hearing status are eligible for study (as long as they can comply with the study primary aims of assessing toxicity and dose-response) Exclusion Criteria: * no preexisting risk of serious arrhythmia as defined by (a) normal sinus rhythm on electrocardiogram and corrected QT interval \<500 and (b) no previous history of congenital arrhythmia (e.g. Wolf-Parkinson-White) * Hepatic, biliary, cardiac, or bone marrow function inadequate for chemotherapy as per patient's treatment regimen. There are no additional protocol-specific restrictions for these markers. * Moderate or Severe Persistent Asthma as defined by the latest recommendations from the National Heart Lung and Blood Institute definition includes daily asthma exacerbation with need for rescue medication) or an overnight hospitalization for asthma exacerbation within the previous 28 days * Disseminated disease (e.g. lepto-meningeal spread, tumor metastases) * Karnofsky or Lansky score \<50% * Pregnancy or breast-feeding mothers * Documented hypersensitivity or allergy to previous NAC infusion
References
Publications (0)
Data not yet available
No reference posted for this study.