Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Phase 2

Terminated

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Drug: Dextromethorphan

• Registration Number: NCT02271893
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Study Start: 2014-11-25
• Primary Completion: 2017-10-26
• Study Completion: 2022-04-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextromethorphan	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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of analgesic consumption	at 1 month
Cognitive assessment by Trail Making Test A and B	at 1 month
Cognitive assessment by FACT-COG test	at 1 month
Quality of life assessment by EORTC QLQ-C30	at 1 month
total neuropathy score clinical version (TNSc)	at 1 month
St Antoine questionnaire (QDSA)	at 1 month
Cognitive assessment by Digit Symbol Substitution Test	at 1 month
Pain assessment by DN4	at 1 month
Cognitive assessment by Purdue Pegboard Test	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

Trial Locations

Locations (1)

Lise LACLAUTRE; 🇫🇷 Clermont-Ferrand, France