NAC to Prevent Cisplatin-induced Hearing Loss (NCT02094625) | Clinical Trial Compass
CompletedPhase 1
NAC to Prevent Cisplatin-induced Hearing Loss
United States52 participantsStarted 2016-03
Plain-language summary
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.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
What they're measuring
1
Target Serum Level NAC
Timeframe: On average up to 4 weeks from diagnosis