CompletedPhase 2ACTRN12611000514909

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


Sponsor

Prince of Wales Hospital/South Eastern Sydney Local Health Network

Enrollment

100 participants

Start Date

Jul 4, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether the drug riluzole can prevent nerve damage (peripheral neuropathy) caused by oxaliplatin chemotherapy in patients with colorectal cancer. Chemotherapy-induced nerve injury can cause numbness, tingling, and pain in the hands and feet, and currently there is no proven way to prevent it.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 t

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.


Locations(1)

Prince of Wales Hospital - Randwick

NSW, Australia

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ACTRN12611000514909