N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy - Full Text View

Sponsored by:	Rijnstate Hospital
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00637624

Purpose

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 lungcancer with chemotherapy containing cisplatin.

Condition	Intervention
Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Lung Mesothelioma	Drug: N-Acetylcysteine Drug: Placebo

MedlinePlus related topics: Antioxidants Cancer Mesothelioma

Drug Information available for: Cisplatin Acetylcysteine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

The occurrence of peripheral neuropathy: with the peripheral neuropathy score (PNP-score) and the electrophysiological measurements. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

haematological abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
creatinine clearance. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
liver chemistry abnormalities [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Karnofski Performance Score [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator N-Acetylcysteine	Drug: N-Acetylcysteine oral 3 times daily 600 mg N-Acetylcysteine en intravenous once every 3 weeks 40 mg/kg
2: Placebo Comparator Placebo	Drug: Placebo Placebo 3 times daily 600 mg and once every 3 weeks intravenous saline fluid

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637624

Contacts

Contact: Idris Bahce, M.D.	+31263788888 ext 3652	IBahce@alysis.nl
Contact: Hans Smit, MD	+31263788888 ext 3030	HSmit@alysis.nl

Locations

Netherlands, Gelderland
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800TA

Sponsors and Collaborators

Rijnstate Hospital

Investigators

Principal Investigator:

Idris Bahce, MD

Rijnstate Hospital

More Information

Responsible Party:	Rijnstate Hospital ( I Bahce )
Study ID Numbers:	LTC-510-100108-Bahce, CCMO: NL19614.091.07, EudraCT: 2007-002787-95
Study First Received:	March 11, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00637624
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:

Acetylcysteine
Cisplatin
Neuropathy
Antioxidants

Study placed in the following topic categories:

Thoracic Neoplasms
Neurotoxicity Syndromes
Carcinoma, Neuroendocrine
Neurotoxicity syndromes
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Neoplasms, Germ Cell and Embryonal
Lung Diseases
Acetylcysteine
Neuroepithelioma
Mesothelioma
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Adenoma
N-monoacetylcystine
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory Tract Neoplasms
Respiratory System Agents
Neoplasms by Histologic Type
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Physiological Effects of Drugs
Neoplasms, Nerve Tissue

Protective Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Expectorants
Therapeutic Uses
Free Radical Scavengers
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009