Does Riluzole reduce the incidence of chemotherapy-induced nerve injury in patients with colorectal cancer?

NEU-HORIZONS: The neuroprotection and therapeutic use of riluzole for the prevention of oxaliplatin neurotoxicity in patients with colorectal cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000514909

Acronym

NEU-HORIZONS

Enrollment

Registered

2011-05-18

Start date

2011-07-04

Completion date

2015-11-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether a drug called Riluzole can prevent chemotherapy-induced nerve injury in patients with colorectal cancer. Who is it for? You can join this study if you are aged 18-80 years and are scheduled to undergo chemotherapy with the drug, oxaliplatin, for the treatment of colorectal cancer. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will take the study drug, Riluzole, at a dose of 50 mg oral tablet twice daily for the duration of chemotherapy treatment (4-6 months), and for 2 weeks following treatment cessation. The other group will receive a placebo (sham) treatment consisting of lactose tablets. During the trial, participants will not know whether they are receiving the active drug or placebo. Participants will be assessed at regular intervals over 2 years to assess their nerve function, quality of life, and cancer-related outcomes.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Receiving oxaliplatin chemotherapy. 2. 18-80 years of age. 3. Able to provide written informed consent. 4. Histological or cytological confirmation of colorectal cancer.

Exclusion criteria

1. Baseline clinical and nerve conduction evidence of pre-existing neuropathy. 2. Past history of neurotoxic chemotherapy treatment. 3. Concurrent use of anticonvulsant medications that modulate axonal Na+ conductances (carbamazepine, topiramate, phenytoin). 4. Evidence of baseline elevation of hepatic transaminases (greater than 3 times the upper limit of normal) on liver function testing. 5. Administration of another investigational drug within 30 days prior to randomisation. 6. A history of severe hypersensitivity reactions to riluzole or any of the tablet components 7. Significant neurological or psychiatric disorders. 8. Pregnancy or lactation. Contraception is required in pre-menopausal female patients.

Outcome results