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. - NAC-PNP-study

Phase 1

Conditions: Cisplatin-induced peripheral neuropathy will be investigated.
MedDRA version: 9.1Level: LLTClassification code 10036109Term: Polyneuropathy due to drugs

Registration Number: EUCTR2007-002787-95-NL

Lead Sponsor: Department of Pulmonology, Rijnstate Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: establishing the efficacy of N-acetylcysteine in preventing cisplatin induced peripheral neuropathy;Secondary Objective: establishing the efficacy of N-acetylcysteine in preventing cisplatin induced hematologic disorders, the effect of N-acetylcysteine on quality of life and tumor response;Primary end point(s): The main study parameter is the occurrence of peripheral neuropathy: therefore the NAC-arm and the placebo-arm will be compared regarding the changes in percent in the peripheral neuropathy score (PNP-score) and in electrophysiological measurements between baseline and endpoint. <br>

Secondary Outcome Measures