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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29356

Enrollment

Registered

2007-09-01

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

NSCLC, non-small cell lung cancer, SCLC, small cell lung cancer, malignant mesothelioma, neuropathy due to cisplatin, niet kleincellig longcarcinoom, kleincellig longcarcinoom, mesothelioom, neuropathie door cisplatin

Interventions

Patients will be randomized in a placebo-arm and a NAC-arm. They will receive oral study-medication (NAC or placebo) three times a day and they will receive intravenous study-medication every 3 weeks,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnose is histologically or cytologically proven (NSCLC,SCLC), malignant mesothelioma (histologically); 2. At least 4 cycles of cisplatin are planned. 3. Adequate renal function (creatinine clearance as calculated by Cockroft-Gault method > 60 ml/min); 4. Karnofski performance score > 60 %; 5. Written informed consent; 6. Patient must be able to comply with study measurements i.e. hospital visits for EMG and QoL assessments; 7. Age >= 18 years;

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing neuropathy; 2. Patients not willing to stop earlier prescribed NAC; 3. Patients not willing to stop vitamins E and A above daily advisory dosage; 4. Uncontrolled metastasis in the central or peripheral nervous system.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the occurrence of peripheral neuropathy: therefore the NAC-arm and the placebo-arm will be compared regarding the peripheral neuropathy score (PNP-score) and the electrophysiological measurements.	—

Secondary

Measure	Time frame
Secondary parameters are the occurrence of differences in haematological pathology, creatinine clearance, liver chemistry and KPS, between the NAC-arm compared to the placebo-arm. Quality of Life will be assessed according to the EORTC QLQ-questionnaire. Differences in tumour response between the two groups will be compared.	—

Contacts

Public ContactI. Bahce

Polikliniek Longziekten Wagnerlaan 55

IBahce@alysis.nl026 378 88 88

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)