Status:
TERMINATED
N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy
Lead Sponsor:
Rijnstate Hospital
Conditions:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Background of the study: Cisplatin (CDDP) is a major compound in chemotherapy in patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and malignant mesothelioma. Cisplatin ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00637624
Start Date
March 1 2008
End Date
July 1 2017
Last Update
August 25 2022
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800TA