Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Lung Mesothelioma

Keywords

AcetylcysteineCisplatinNeuropathyAntioxidants

Outcome Measures

Primary Outcomes (1)

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.
5 months

Secondary Outcomes (5)

haematological abnormalities
5 months
creatinine clearance.
5 months
liver chemistry abnormalities

Study Arms (2)

1

ACTIVE COMPARATOR

N-Acetylcysteine

Drug: N-Acetylcysteine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

N-AcetylcysteineDrug

N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg

Also known as: Fluimucil

PlaceboDrug

Placebo once every 3 weeks intravenous saline fluid

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

diagnose is histologically or cytologically proven (NSCLC,SCLC), malignant mesothelioma (histologically)
at least 4 cycles of cisplatin are planned

Sponsors & Collaborators

Rijnstate Hospital
Otherlead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800TA, Netherlands

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaMesothelioma

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenoma

Study Officials

Idris Bahce, MD
Rijnstate Hospital
PRINCIPAL INVESTIGATOR

Enrollment

69 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

March 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations