Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05382520
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2022-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Pilot and Feasibility study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNAS', 'timeFrame': '2 years', 'description': 'TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status'}, {'measure': 'VAS', 'timeFrame': '2 years', 'description': '0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week.'}, {'measure': 'FABS', 'timeFrame': '2 years', 'description': 'Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.'}, {'measure': 'TUG', 'timeFrame': '2 years', 'description': 'Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.'}, {'measure': 'NSA', 'timeFrame': '2 years', 'description': 'Nottingham Sensory Assessment: sensory detection and discrimination test'}, {'measure': 'Semmes-Weinstein monofilament testing', 'timeFrame': '2 years', 'description': 'tactile detection threshold'}, {'measure': 'LEPT', 'timeFrame': '2 years', 'description': 'Lower Extremity Position Test: proprioception detection and quantification'}, {'measure': 'Allodynia', 'timeFrame': '2 years', 'description': 'tested by non-painful mechanical stimulation: gentle brushing and monofilament'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Chemo Induced Peripheral Neuropathy (CIPN)', 'Sensory rehabilitation', 'Explicit Sensory Retraining'], 'conditions': ['CIPN']}, 'descriptionModule': {'briefSummary': 'Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.\n\nExclusion Criteria:\n\n1. Sensory damage / neuropathy that existed even before the start of chemotherapy\n2. Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)\n3. Central nervous system involvement\n4. Major pre-morbid orthopedic lower limb impairment\n5. Hebrew language not sufficient for assessment and treatment"}, 'identificationModule': {'nctId': 'NCT05382520', 'briefTitle': 'Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)', 'orgStudyIdInfo': {'id': '0057-22-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Explicit sensory retraining for lower extremity in individuals with CIPN', 'description': 'Explicit sensory retraining for lower extremity function (pain, sensory, balance, gait). five one-hour sessions, a week apart: Pre-Post assessment sessions with 3 treatment sessions in between. Home exercise assigned.', 'interventionNames': ['Diagnostic Test: Questionares and practice']}], 'interventions': [{'name': 'Questionares and practice', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionares and practice', 'armGroupLabels': ['Explicit sensory retraining for lower extremity in individuals with CIPN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beer Yaaqov', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nicole Asaraf', 'role': 'CONTACT', 'phone': '972-544699403'}, {'name': 'Rotem Maroz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shamir medical center'}], 'centralContacts': [{'name': 'Hadas Ofek', 'role': 'CONTACT', 'email': 'hadasbarkolofek@gmail.com', 'phone': '972544666412'}, {'name': 'Nicole Asraf', 'role': 'CONTACT', 'email': 'nicoleas000@gmail.com', 'phone': '972544699403'}], 'overallOfficials': [{'name': 'Rotem Merose, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assaf Harofee MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Zefat Academic College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Breast Oncologist', 'investigatorFullName': 'Rotem Merose', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}