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Can a common drug stop Chemo's nerve pain?

NCT ID NCT03722680

Prevention Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests whether riluzole, a drug used for ALS, can prevent nerve damage caused by oxaliplatin chemotherapy in people with stage II/III colorectal cancer. About 80 participants will receive either riluzole or a placebo during their chemo. The study is currently suspended, so results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
riluzole
What this could lead to
If it works, this could point toward a way to prevent nerve damage from oxaliplatin chemotherapy, helping patients avoid pain and numbness.
What could go wrong
This is a small, early-phase trial that is currently suspended, so results may not be reliable. The drug may not prevent nerve damage or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

80 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged ≥ 18 years old, 2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles, Simplified FOLFOX4) for stage II/III colorectal cancer, 3. Histological or cytological confirmation of colorectal cancer, 4. Performance status (ECOG) ≤2, 5. Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; hemoglobin ≥9.0 g/dL), 6. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN, 7. Normal renal function: serum creatinine ≤1.5 x ULN, 8. Normal cardiac function: ECG, 9. Patients affiliated to the French national health insurance, 10. Patient must have signed a written informed consent form prior to any study specific procedures, 11. French language comprehension, 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: 1. Metastatic cancer, 2. Diagnosis of neuropathy, 3. EORTC QLQ-CIPN20 sensory score \>6, 4. Previous neurotoxic chemotherapy treatment, 5. Patients with chronic obstructive pulmonary disease, 6. ALAT/ASAT elevated more than 3 times the normal value, 7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients, 8. Dependence on alcohol or drugs, 9. Psychotic disorders, 10. Women pregnant or breastfeeding, 11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm chemotherapy-induced neuropathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oxaliplatin-induced peripheral neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annecy-Genevois

    Pringy, France

  • CH Beauvais

    Beauvais, France

  • CHU de Clermont -Ferrand

    Clermont-Ferrand, France

  • CHU de Dijon

    Dijon, France

  • CHU de Reims

    Reims, France

  • CHU de Saint-Etienne

    Saint-Priest, France

  • Centre François Baclesse

    Caen, France

  • Centre Georges François Leclerc

    Dijon, France

  • Clinique St Côme

    Compiègne, France

  • GHPSO

    Creil, France

  • Hia Begin

    Saint-Mandé, France

  • Hia Percy

    Clamart, France

  • Hôpital Foch

    Suresnes, France

  • ICO - Site Paul Papin

    Angers, France

  • ICO - Site René Gauducheau

    Saint-Herblain, France

  • Institut Jean Godinot

    Reims, France

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