Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 10:42 AM
Study NCT ID:
NCT03816904
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2019-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of SK3 Calcium Channel in Taxane Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'assay number of CAG triplets composing the KCNN3 gene usual blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of a neuropathy secondary to taxanes using Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)', 'timeFrame': 'From baseline and up to 4 months of follow-up', 'description': 'Evaluation of neuropathy will be performed using non-invasive test, gold standard, Cancer Institute Common Terminology Criteria for Adverse Events\n\nGrading (from best to worst) :\n\n0 = normal\n\n1. = slight paresthesia, mild weakness (subjective)\n2. = moderate paresthesia, moderate weakness (objective)\n3. = severe paresthesia with functional disability, severe weakness\n4. = paralysis'}, {'measure': 'Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)', 'timeFrame': 'From baseline and up to 4 months of follow-up', 'description': 'Evaluation of neuropathy will be performed using non-invasive test, Total neuropathy score clinical\n\nGrading (from best to worst) :\n\nSensory symptoms : 0 = none (N), 1 = symptoms limited finger or toes, 2 = Symptoms extend to ankle or wrist, 3 = Symptoms extend to knee or elbow, 4 = Symptoms above knees or elbow or functionally disabling Motor symptoms : 0 = N, 1 = slight difficulty, 2 = moderate difficulty, 3 = require help/assistance, 4 = paralysis Autonomic symptoms : 0 = N, 1 , 2, 3, 4 (number of symptoms) Pin sensibility and vibration sensibility : 0 = normal (n), 1 = reduced in fingers/toes, 2 = reduced to wrist/ankle, 3 = reduced to elbow/knee, 4 = reduced to above elbow/knee Strength : 0 = n, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, 4 = paralysis Deep tendon reflexe : 0 = n, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent, other reduced, 4 = all reflexes absent'}], 'secondaryOutcomes': [{'measure': 'Occurence of adverses events to taxanes (dysgeusia, myalgia, digestive toxicity tearing, onycholysis.)', 'timeFrame': 'From baseline and up to 4 months of follow-up', 'description': 'Each adverse event will be evaluated using CTCAE score grading (from best to worst) :\n\n* 0 : none\n* 1 : minimal\n* 2 : moderate\n* 3 : severe\n* 4 : very severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Chemotherapy-induced Peripheral Neuropathy', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its pathophysiology is poorly known and probably multifactorial. A possible mechanism would be mediated by the activation of the SK3 calcium channel: a retrospective study carried out at the University Hospital of Tours (Carina RUA) found a significant association between the number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a taxane neuropathy.', 'detailedDescription': 'Patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.\n\nThe mode of administration of chemotherapy and the usual follow-up will not be modified by the protocol The determination of the SK3 status will be made from an additional tube collected during a collection as part of the treatment at the first arrival in a day hospital (no more blood tests). Blood sample of 7mL. Shipments and analyzes of samples in Tours in the pharmacogenetics laboratory under the responsibility of Dr. BARIN-LE GUELLEC.\n\nThis study is non-invasive, without impact on the therapeutic management. The result of the polymorphism of SK3 will not be indicated in the record, so as not to influence the follow-up of the treatment and to allow an evaluation of the occurrence of peripheral neuropathy in blindness of the number of repetitions of the CAG triplet of the KCNN3 gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in oncology day hospital for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nBreast Group\n\n* Age ≥ 18 years\n* Breast cancer\n* Chemotherapy with paclitaxel or docetaxel\n* Adjuvant or neoadjuvant chemotherapy in localized cancer or first-line treatment in metastatic cancer\n* Signed informed consent\n\nProstate Group\n\n* Age ≥ 18 years\n* Metastatic prostate cancer\n* Chemotherapy with docetaxel in 1st line\n* Signed informed consent\n\nExclusion Criteria:\n\n* Anteriority or concomitance of another chemotherapy provider of neuropathy (platinum salts)\n* Another possible cause of neuropathy: diabetes, alcoholism, vitamin B9 / B12 deficiency, neurodegenerative disease, Raynaud's syndrome"}, 'identificationModule': {'nctId': 'NCT03816904', 'acronym': 'NEUROTAX', 'briefTitle': 'Involvement of SK3 Calcium Channel in Taxane Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Involvement of SK3 Calcium Channel in Taxane Neuropathy', 'orgStudyIdInfo': {'id': 'RIPH3-RNI18/NEUROTAX'}, 'secondaryIdInfos': [{'id': '2018-A02884-51', 'type': 'OTHER', 'domain': 'IdRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast or prostate cancer', 'description': 'Taken blood samples on patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer', 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'description': 'Blood samples before the introduction of chemotherapy', 'armGroupLabels': ['Breast or prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37500', 'city': 'Chinon', 'country': 'France', 'facility': 'Department of Oncology, Hospital, Chinon', 'geoPoint': {'lat': 47.16701, 'lon': 0.24284}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Department of Medical Oncology, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Catherine BARBE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}