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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002787-95-NL
Enrollment
Unknown
Registered
2007-09-03
Start date
2008-01-03
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Fluimucil Pharmaceutical Form: Intravenous infusion INN or Proposed INN: N-acetylcysteine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number:

Sponsors

Department of Pulmonology, Rijnstate Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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) - 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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026