N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy (NAC-PNP)

Primary Outcome Measures:

• The occurrence of peripheral neuropathy: with the peripheral neuropathy score (PNP-score) and the electrophysiological measurements. If no EMG is available, then audiometric measurements will be taken into account. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• haematological abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
• creatinine clearance. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
• liver chemistry abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
• Karnofski Performance Score [ Time Frame: 5 months ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Eligibility Criteria

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)
• Karnofsky 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

Exclusion Criteria:

• patients with pre-existing neuropathy
• patients not willing to stop earlier prescribed NAC
• patients not willing to stop vitamins E and A above daily advisory dosage
• uncontrolled metastasis in the central or peripheral nervous system