Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

NCT02271893 | Terminated Phase 2

• 2 other identifiers: CHU-02142014-000971-19
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Measure of average pain intensity by a numerical rating scale

  7 days before the visit at 1 month

Secondary Outcomes (12)

• Pain assessment by DN4

  at 1 month

• total neuropathy score clinical version (TNSc)

  at 1 month

• St Antoine questionnaire (QDSA)

  at 1 month

• Evaluation of analgesic consumption

  at 1 month

• Cognitive assessment by Trail Making Test A and B

  at 1 month

Study Arms (2)

Dextromethorphan

EXPERIMENTAL

The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

Drug: Dextromethorphan

placebo

PLACEBO COMPARATOR

The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

Drug: Dextromethorphan

Interventions

Dextromethorphan DRUG

The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

Dextromethorphan; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years
• Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
• Numerical rating scale ≥ 4
• Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
• Patients affiliated to the French Social Security
• Patients with free and informed consent has been obtained

You may not qualify if:

• \- Hypersensitivity to the active substance or to any of the excipients
• Hypertension
• History of stroke
• Severe heart failure
• Severe hepatic impairment
• Shortness of breath
• Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
• Association with linezolid
• Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
• Diabetes (type I and II)
• Medical and surgical history incompatible with the study
• Patient receiving treatment with amantadine, ketamine, memantine, L-Dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, Monoamine oxidase inhibitor, dantrolene or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, amiodarone, fluoxetine, paroxetine, propafenone, thioridazine, ritonavir, nicotine, hydrochlorothiazide, warfarin
• Present or past psychotropic substances and alcohol dependence
• Childbearing age, no use of effective contraceptive method, pregnancy or lactation
• Patients undergoing a measure of legal protection (guardianship, supervision ...)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Dr Gisèle PICKERING: collaborator
• Dr Dominique JOLY / Dr Christine VILLATTE: collaborator
• Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD: collaborator
• Pr Claude DUBRAY: collaborator

Study Sites (1)

Lise LACLAUTRE

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.

  PMID: 25636304 DERIVED

MeSH Terms

Interventions

Dextromethorphan

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: November 25, 2014
• Primary Completion: October 26, 2017
• Study Completion: April 21, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

FR (1)