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Trial registered on ANZCTR


Registration number
ACTRN12611000514909
Ethics application status
Approved
Date submitted
13/05/2011
Date registered
18/05/2011
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Date results information initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Riluzole reduce the incidence of chemotherapy-induced nerve injury in patients with colorectal cancer?
Scientific title
NEU-HORIZONS: The neuroprotection and therapeutic use of riluzole for the prevention of oxaliplatin neurotoxicity in patients with colorectal cancer
Secondary ID [1] 262128 0
none
Universal Trial Number (UTN)
U1111-1121-2382
Trial acronym
NEU-HORIZONS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxaliplatin-induced neurotoxicity 265801 0
Colorectal cancer 265875 0
Condition category
Condition code
Neurological 265957 265957 0 0
Other neurological disorders
Cancer 266006 266006 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients receiving oxaliplatin chemotherapy for colorectal cancer will be randomised into either the study drug arm or placebo control arm. Participants will be started on either riluzole 50 mg oral tablet twice daily or the twice daily lactose placebo tablet. Following randomisation, therapy will be continued for the duration of oxaliplatin treatment (4-6 months) and for 2 weeks following treatment cessation.
Intervention code [1] 264544 0
Prevention
Comparator / control treatment
Routine clinical care involving standard review by oncology physician and placebo lactose tablet. Symptomatic relief of neuropathic symptoms as required.
Control group
Placebo

Outcomes
Primary outcome [1] 266708 0
To assess whether treatment with riluzole results in a reduction in the development of chronic neuropathy and neuropathic symptoms

The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.
Timepoint [1]