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.
- Conditions
- 10034606hypo-esthesianumbness1003866610029107
- Registration Number
- NL-OMON31618
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the occurrence of peripheral neuropathy: therefore<br /><br>the NAC-arm and the placebo-arm will be compared regarding the peripheral<br /><br>neuropathy score (PNP-score) and the electrophysiological measurements.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are the occurrence of differences in haematological<br /><br>pathology, creatinine clearance, liver chemistry and KPS, between the NAC-arm<br /><br>compared to the placebo-arm. Quality of Life will be assessed according to the<br /><br>EORTC QLQ-questionnaire. Differences in tumour response between the two groups<br /><br>will be compared. </p><br>