Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— CHEMODEX  

Official title:

Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02271893
• Other study ID #: CHU-0214
• Secondary ID: 2014-000971-19
• Status: Terminated
• Phase: Phase 2
• Start date: November 25, 2014
• Est. completion date: April 21, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 21, 2022
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ...)

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Lise LACLAUTRE	Clermont-Ferrand

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of average pain intensity by a numerical rating scale		7 days before the visit at 1 month
Secondary	Pain assessment by DN4		at 1 month
Secondary	total neuropathy score clinical version (TNSc)		at 1 month
Secondary	St Antoine questionnaire (QDSA)		at 1 month
Secondary	Evaluation of analgesic consumption		at 1 month
Secondary	Cognitive assessment by Trail Making Test A and B		at 1 month
Secondary	Cognitive assessment by Digit Symbol Substitution Test		at 1 month
Secondary	Cognitive assessment by FACT-COG test		at 1 month
Secondary	Cognitive assessment by Purdue Pegboard Test		at 1 month
Secondary	Quality of life assessment by EORTC QLQ-C30		at 1 month
Secondary	Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)		at 1 month
Secondary	Quality of life assessment by Patient Global Impression of Change (PGIC)		at 1 month
Secondary	Anxiety and Depression assessment by HAD scale		at 1 month