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

March 18, 2008

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
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