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