Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-27 @ 7:25 AM
Study NCT ID:
NCT04237194
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Nerve fiber excitability', 'timeFrame': 'The difference between baseline and the 6 months follow-up', 'description': 'The chronaxie and the rheobase to rectangular stimuli, the accommodation to triangular stimuli, and the electrotonus to subthreshold hyperpolarizing pre-pulses for large and small sensory nerves from the excitability measure.'}], 'secondaryOutcomes': [{'measure': 'Change of Quantitative sensory test', 'timeFrame': 'The difference between baseline and the 6 months follow-up', 'description': 'The Quantitative sensory test is a reduced version of the German protokol and contains warmth and cold detection thresholds, heat and cold pain thresholds, vibration threshold and perceived intensity to mechanical stimuli.'}, {'measure': 'Changed of CTCAE', 'timeFrame': 'The difference between baseline and the 6 months follow-up', 'description': 'Common Terminology Criteria for Adverse events scale is a scale from 0 to 5, where 5 is worse.'}, {'measure': 'Change of CIPN20.', 'timeFrame': 'The difference between baseline and the 6 months follow-up', 'description': 'Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Twenty-Item scale is a 20-item self-report questionnaire. Items are scored 1-4 with 1 representing "not at all" and 4 "very much." Scores are then linearly converted to a 0-100 scale where 100 is worse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Assessment of nerve fiber excitability'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers', 'detailedDescription': 'Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. To limit the nerve damages, early detection and management of CIPN is crucial and leaves an urgent demand for new diagnostic tools. Perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess CIPN at early stages. The purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment.\n\nIn this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the Nerve excitability of small and large fibers. Further quantitative sensory tests (QST) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. Symptoms of CIPN will be assessed using the Common Terminology Criteria for Adverse events scale and a Quality of Life Questionnaire CIPN twenty-item scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients receiving adjuvant chemotherapy, consisting of 3 cycles of Epirubicin and Cyclophosphamide (EC), followed by 3 cycles of Paclitaxel (9 Paclitaxel infusions).', 'genderDescription': 'Breast Cancer mainly affects women.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\> 18 years\n2. Histopathologically verified breast cancer\n3. Performance Status according to WHO/ECOG (PS) 0-2\n4. Candidate for adjuvant standard treatment with EC and Paclitaxel\n5. Not previously treated with chemotherapeutic agents\n6. Neurological examination without pathological findings\n7. Willingness to voluntarily sign an informed consent\n\nExclusion Criteria:\n\n1. Previously neoadjuvant treatment with chemotherapy\n2. Receives prophylactic bone marrow stimulants\n3. HIV\n4. Diabetes mellitus\n5. Opioid requirement\n6. Symptomatic neurosensory disorders\n7. Neurological diseases, such as sclerosis and epilepsy\n8. Alcohol abuse\n9. "Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet\n10. Cannot understand written or oral information in Danish\n11. Inability to cooperate'}, 'identificationModule': {'nctId': 'NCT04237194', 'acronym': 'PacTox', 'briefTitle': 'A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'N-20190071'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Northern Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Laurids Østergaard Poulsen, PhD', 'role': 'CONTACT', 'email': 'laop@rn.dk', 'phone': '97666795'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Laurids Ø Poulsen, MD, PhD', 'role': 'CONTACT', 'email': 'laop@rn.dk', 'phone': '+45 97666795'}, {'name': 'Helena Brøckner, Ba.Sc', 'role': 'CONTACT', 'email': 'hbrack15@student.aau.dk', 'phone': '+4529702992'}], 'overallOfficials': [{'name': 'Laurids Ø Poulsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carsten Dahl Mørch', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Carsten Dahl Mørch', 'investigatorAffiliation': 'Aalborg University'}}}}