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Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management (CHEMODEX)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dextromethorphan
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Chemotherapy-induced peripheral neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 ...)

Sites / Locations

  • Lise LACLAUTRE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dextromethorphan

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measure of average pain intensity by a numerical rating scale

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2014
Last Updated
October 6, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT02271893
Brief Title
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Acronym
CHEMODEX
Official Title
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
Chemotherapy-induced peripheral neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextromethorphan
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
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 Measure Information:
Title
Measure of average pain intensity by a numerical rating scale
Time Frame
7 days before the visit at 1 month
Secondary Outcome Measure Information:
Title
Pain assessment by DN4
Time Frame
at 1 month
Title
total neuropathy score clinical version (TNSc)
Time Frame
at 1 month
Title
St Antoine questionnaire (QDSA)
Time Frame
at 1 month
Title
Evaluation of analgesic consumption
Time Frame
at 1 month
Title
Cognitive assessment by Trail Making Test A and B
Time Frame
at 1 month
Title
Cognitive assessment by Digit Symbol Substitution Test
Time Frame
at 1 month
Title
Cognitive assessment by FACT-COG test
Time Frame
at 1 month
Title
Cognitive assessment by Purdue Pegboard Test
Time Frame
at 1 month
Title
Quality of life assessment by EORTC QLQ-C30
Time Frame
at 1 month
Title
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time Frame
at 1 month
Title
Quality of life assessment by Patient Global Impression of Change (PGIC)
Time Frame
at 1 month
Title
Anxiety and Depression assessment by HAD scale
Time Frame
at 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ...)
Facility Information:
Facility Name
Lise LACLAUTRE
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25636304
Citation
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.
Results Reference
derived

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Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

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