NCT00637624

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 chemotherapy containing cisplatin.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

9.3 years

First QC Date

March 11, 2008

Last Update Submit

August 22, 2022

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Small Cell LungMesothelioma

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

    5 months

  • Karnofski Performance Score

    5 months

  • Quality of life

    5 months

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
1
PlaceboDRUG

Placebo once every 3 weeks intravenous saline fluid

2

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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800TA, Netherlands

Location

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 DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Idris Bahce, MD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

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 1, 2008

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

NL(1)