Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT05156060
Status:
RECRUITING
Last Update Posted:
2024-10-21
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-22', 'size': 1440499, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-08T09:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)', 'timeFrame': 'Approximately 28 days (Phase I)', 'description': 'Up to a maximum planned dose of 40 mg three times a day'}, {'measure': 'Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)', 'timeFrame': 'Up to 30 post-treatment (Phase II)', 'description': 'Number of Participants With Grade 3 or 4 Adverse Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Locally Advanced Head and Neck Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.', 'detailedDescription': 'Objectives:\n\n* To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.\n* To evaluate feasibility and tolerability\n\nExploratory:\n\n\\- To assess pain, symptom burden, functionality, and quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven cancer of the head and neck cancer\n* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)\n* Planned primary or adjuvant radiation or chemoradiation therapy\n* Willing and able to provide informed consent\n* ECOG PS 0-2\n* Age ≥ 21 years\n* English speaking\n\nExclusion Criteria:\n\n* Currently on gabapentin or ketamine\n* Prior non-tolerance of gabapentin or ketamine\n* Unable to administer ketamine intranasally due to anatomical restrictions\n* History of seizure disorder\n* History of schizophrenia\n* History of increased intracranial pressure\n* Glomerular filtration rate \\<30 mL/min/1.73 m2'}, 'identificationModule': {'nctId': 'NCT05156060', 'briefTitle': 'Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation', 'orgStudyIdInfo': {'id': 'VICC HNP 2173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin plus Ketamine', 'description': 'Gabapentin and Ketamine will be taken 3 times per day.', 'interventionNames': ['Drug: Gabapentin', 'Drug: Ketamine']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'Taken by mouth 3 times per day', 'armGroupLabels': ['Gabapentin plus Ketamine']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'Administered intranasally 3 times per day', 'armGroupLabels': ['Gabapentin plus Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Service for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Natalie Lockney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Vanderbilt-Ingram Service for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}], 'overallOfficials': [{'name': 'Natalie Lockney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natalie Lockney', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'Natalie Lockney', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}