Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management (CHEMODEX)

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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Drug: Dextromethorphan

Detailed Description

This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.

The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Lise Laclautre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• - 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

Exclusion Criteria:

• - 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
• Patient exclusion period, or the total allowable compensation exceeded
• Patients undergoing a measure of legal protection (guardianship, supervision ...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextromethorphan; 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; 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.
Placebo Comparator: placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of average pain intensity by a numerical rating scale	7 days before the visit at 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cognitive assessment by Digit Symbol Substitution Test	at 1 month
Cognitive assessment by FACT-COG test	at 1 month
Cognitive assessment by Purdue Pegboard Test	at 1 month
Quality of life assessment by EORTC QLQ-C30	at 1 month
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)	at 1 month
Quality of life assessment by Patient Global Impression of Change (PGIC)	at 1 month
Anxiety and Depression assessment by HAD scale	at 1 month

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2014
• Primary Completion (Actual): October 26, 2017
• Study Completion (Actual): April 21, 2022

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Chemotherapy-induced peripheral neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: CHU-0214; 2014-000971-19 (EudraCT Number)