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N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy (NAC-PNP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637624
First Posted: March 18, 2008
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rijnstate Hospital
  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 lung cancer with chemotherapy containing cisplatin.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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. If no EMG is available, then audiometric measurements will be taken into account. [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • haematological abnormalities [ Time Frame: 5 months ]
  • creatinine clearance. [ Time Frame: 5 months ]
  • liver chemistry abnormalities [ Time Frame: 5 months ]
  • Karnofski Performance Score [ Time Frame: 5 months ]
  • Quality of life [ Time Frame: 5 months ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
N-Acetylcysteine
Drug: N-Acetylcysteine
N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg
Other Name: Fluimucil
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo once every 3 weeks intravenous saline fluid

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637624


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

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6800TA
Contact: Idris Bahce, MD    +31263788888 ext 3652    I.Bahce@VUmc.nl   
Principal Investigator: Idris Bahce, MD         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Idris Bahce, MD Rijnstate Hospital
  More Information

Responsible Party: I Bahce, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00637624     History of Changes
Other Study ID Numbers: LTC-510-100108-Bahce
CCMO: NL19614.091.07
EudraCT: 2007-002787-95
First Submitted: March 11, 2008
First Posted: March 18, 2008
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Rijnstate Hospital:
Acetylcysteine
Cisplatin
Neuropathy
Antioxidants

Additional relevant MeSH terms:
Carcinoma
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Neurotoxicity Syndromes
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenoma
Neoplasms, Mesothelial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants