Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-18 @ 4:13 AM
Study NCT ID:
NCT02271893
Status:
TERMINATED
Last Update Posted:
2022-10-10
First Post:
2014-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003915', 'term': 'Dextromethorphan'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of average pain intensity by a numerical rating scale', 'timeFrame': '7 days before the visit at 1 month'}], 'secondaryOutcomes': [{'measure': 'Pain assessment by DN4', 'timeFrame': 'at 1 month'}, {'measure': 'total neuropathy score clinical version (TNSc)', 'timeFrame': 'at 1 month'}, {'measure': 'St Antoine questionnaire (QDSA)', 'timeFrame': 'at 1 month'}, {'measure': 'Evaluation of analgesic consumption', 'timeFrame': 'at 1 month'}, {'measure': 'Cognitive assessment by Trail Making Test A and B', 'timeFrame': 'at 1 month'}, {'measure': 'Cognitive assessment by Digit Symbol Substitution Test', 'timeFrame': 'at 1 month'}, {'measure': 'Cognitive assessment by FACT-COG test', 'timeFrame': 'at 1 month'}, {'measure': 'Cognitive assessment by Purdue Pegboard Test', 'timeFrame': 'at 1 month'}, {'measure': 'Quality of life assessment by EORTC QLQ-C30', 'timeFrame': 'at 1 month'}, {'measure': 'Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)', 'timeFrame': 'at 1 month'}, {'measure': 'Quality of life assessment by Patient Global Impression of Change (PGIC)', 'timeFrame': 'at 1 month'}, {'measure': 'Anxiety and Depression assessment by HAD scale', 'timeFrame': 'at 1 month'}]}, 'conditionsModule': {'keywords': ['Chemotherapy-induced peripheral neuropathy'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '25636304', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Age ≥ 18 years\n* Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy\n* Numerical rating scale ≥ 4\n* 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)\n* Patients affiliated to the French Social Security\n* Patients with free and informed consent has been obtained\n\nExclusion Criteria:\n\n* \\- Hypersensitivity to the active substance or to any of the excipients\n* Hypertension\n* History of stroke\n* Severe heart failure\n* Severe hepatic impairment\n* Shortness of breath\n* Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency\n* Association with linezolid\n* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy\n* Diabetes (type I and II)\n* Medical and surgical history incompatible with the study\n* 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\n* Present or past psychotropic substances and alcohol dependence\n* Childbearing age, no use of effective contraceptive method, pregnancy or lactation\n* Patient exclusion period, or the total allowable compensation exceeded\n* Patients undergoing a measure of legal protection (guardianship, supervision ...)'}, 'identificationModule': {'nctId': 'NCT02271893', 'acronym': 'CHEMODEX', 'briefTitle': 'Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management', 'orgStudyIdInfo': {'id': 'CHU-0214'}, 'secondaryIdInfos': [{'id': '2014-000971-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dextromethorphan', '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.', 'interventionNames': ['Drug: Dextromethorphan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', '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.', 'interventionNames': ['Drug: Dextromethorphan']}], 'interventions': [{'name': 'Dextromethorphan', 'type': 'DRUG', '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.', 'armGroupLabels': ['Dextromethorphan', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Lise LACLAUTRE', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Gisèle PICKERING', 'class': 'UNKNOWN'}, {'name': 'Dr Dominique JOLY / Dr Christine VILLATTE', 'class': 'UNKNOWN'}, {'name': 'Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD', 'class': 'UNKNOWN'}, {'name': 'Pr Claude DUBRAY', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}