Clinical trial · Interventional
N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy
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
NCT00637624CI-TRIAL-00060551NAC-PNPterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit enough patients
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Carcinoma, Small Cell Lung | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-Acetylcysteine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- N-Acetylcysteine
- interventionNames
- Drug: N-Acetylcysteine
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The occurrence of peripheral neuropathy: with the peripheral neuropathy score (PNP-score) and the electrophysiological measurements. If no EMG is available, then audiometric measurements will be taken into account.
- timeFrame
- 5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.