Overview
N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy
Status:
Unknown status
Unknown status
Trial end date:
2012-02-01
2012-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lung cancer with chemotherapy containing cisplatin.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Rijnstate HospitalTreatments:
Acetylcysteine
N-monoacetylcystine
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