A randomized double-blind study of N-Acetylcysteine vs. placebo to Prevent Neurotoxicity induced by Platinum containing chemotherapy in patients treated for (Non)Small Cell Lung Cancer and Malignant Mesothelioma.

INTERVENTION: Trade Name: Fluimucil Pharmaceutical Form: Intravenous infusion INN or Proposed INN: N‐acetylcysteine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Fluimucil Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: N‐acetylcysteine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Cisplatin‐induced peripheral neuropathy will be investigated. ; MedDRA version: 9.1 Level: LLT Classification code 10036109 Term: Polyneuropathy due to drugs PRIMARY OUTCOME: Main Objective: establishing the efficacy of N‐acetylcysteine in preventing cisplatin induced peripheral neuropathy Primary end point(s): The main study parameter is the occurrence of peripheral neuropathy: therefore the NAC‐arm and the placebo‐arm will be compared regarding the changes in percent in the peripheral neuropathy score (PNP‐score) and in electrophysiological measurements between baseline and endpoint. ; Secondary Objective: establishing the efficacy of N‐acetylcysteine in preventing cisplatin induced hematologic disorders, the effect of N‐acetylcysteine on quality of life and tumor response INCLUSION CRITERIA: ‐diagnose is histologically or cytologically proven (NSCLC,SCLC), malignant mesothelioma (histologically) ‐at least 4 cycles of cisplatin are planned ‐adequate renal function (creatinine clearance as calculated by Cockroft‐Gault method > 60 ml/min) ‐ Karnofski performance score > 60 % ‐written informed consent ‐patient must be able to comply with study measurements i.e. hospital visits for EMG and QoL assessments ‐age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range