Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 25, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Pain assessment by DN4
    • Time Frame: at 1 month
  • total neuropathy score clinical version (TNSc)
    • Time Frame: at 1 month
  • St Antoine questionnaire (QDSA)
    • Time Frame: at 1 month
  • Evaluation of analgesic consumption
    • Time Frame: at 1 month
  • Cognitive assessment by Trail Making Test A and B
    • Time Frame: at 1 month
  • Cognitive assessment by Digit Symbol Substitution Test
    • Time Frame: at 1 month
  • Cognitive assessment by FACT-COG test
    • Time Frame: at 1 month
  • Cognitive assessment by Purdue Pegboard Test
    • Time Frame: at 1 month
  • Quality of life assessment by EORTC QLQ-C30
    • Time Frame: at 1 month
  • Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
    • Time Frame: at 1 month
  • Quality of life assessment by Patient Global Impression of Change (PGIC)
    • Time Frame: at 1 month
  • Anxiety and Depression assessment by HAD scale
    • Time Frame: at 1 month

Participating in This Clinical Trial

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 …)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • Dr Gisèle PICKERING
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

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