Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT06724861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will not be aware of randomization and allocation. Primary investigator and statistician will receive data ready for analysis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A Randomized Controlled Trial will be conducted in a within-subject cross-over design (AB BA). Full assessments will be conducted at baseline, after last treatment session. A short assessment will be conducted at the beginning of all sessions. The early intervention group (AB) will be assessed at one-month follow-up in addition. The later intervention group (BA) will be assessed at baseline, and after a month before treatment commences and immediately after last treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Home exercise log', 'timeFrame': '1 minutes writing daily at home', 'description': 'Amount of home exercise per minutes per day'}, {'measure': 'Participant satisfaction questionnaire', 'timeFrame': '5 minutes, at final assessment session only', 'description': 'Participant satisfaction questionnaire'}], 'primaryOutcomes': [{'measure': 'Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)', 'timeFrame': 'from randomization 3 months maximum', 'description': 'TNAS -Treatment-Induced Neuropathy Assessment Scale: patient-reported outcome measure of presence and severity of CIPN. Nine 0-10 question scale. score 0-90. A higher score is for higher CIPN symptom severity.'}, {'measure': 'Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)', 'timeFrame': 'from randomization to maximum 3 months followup', 'description': 'TUG -Timed Up and Go: Balance and mobility assessment. Serves as a fall prediction screening test. Measures time taken to raise from a chair walking 3 meters and re-sit.'}, {'measure': 'Pain intensity: VAS - 0-100 mm visual scale', 'timeFrame': 'from randomization to maximum 3 months', 'description': 'Pain intensity: VAS - 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'}], 'secondaryOutcomes': [{'measure': 'Tactile function assessment - Semmes Weinstein Monofilaments (SWM)', 'timeFrame': 'from randomization to maximum 3 months followup', 'description': 'Sensory threshold at the foot, as measured by Semmes Weinstein filaments.'}, {'measure': 'FABS - Fullerton Advanced Balance Scale', 'timeFrame': 'from randomization to maximum 3 months', 'description': 'FABS - 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': 'Proprioception of lower extremity: Lower Extremity Position Test (LEPT)', 'timeFrame': 'from randomization to maximum 3 months followup', 'description': 'Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Chemo Induced Peripheral Neuropathy (CIPN)', 'Sensory rehabilitation', 'Explicit Sensory Retraining', 'Lower extremity'], 'conditions': ['CIPN - Chemotherapy-Induced Peripheral Neuropathy', 'Age Over 18', 'Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.', 'detailedDescription': "Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.\n\nNeuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.\n\nCIPN is associated with lower self-reported physical function and Quality of Life (QoL).\n\nThe clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.\n\nDamage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.\n\nActive, explicit sensory rehabilitation is efficient in promoting sensation and function in individuals with neurological conditions, such as stroke and multiple sclerosis. To the best of our knowledge although CIPN is primarily a sensory deficit there is no treatment aimed at this aspect. We aim to conduct a pilot study to explore the feasibility and clinical benefit of an active, explicit sensory rehabilitation protocol for the lower limb in individuals with chronic CIPN.\n\nThis study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* CIPN by self-report (present or absent) \\> 3 months after last chemotherapy treatment\n* age \\> 18.\n\nExclusion Criteria:\n\n* Pre-chemotherapy neuropathy/ sensory impairment\n* recurrent falls prior to chemotherapy (more than 2 per year)\n* CNS involvement\n* not ambulatory before chemotherapy\n* Hebrew proficiency not meeting questionnaires' needs."}, 'identificationModule': {'nctId': 'NCT06724861', 'briefTitle': 'Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Sensory Rehabilitation in CIPN', 'orgStudyIdInfo': {'id': 'CIPN - RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AB - early experimental treatment, later control usual care', 'description': 'AB - early experimental treatment, later control usual care', 'interventionNames': ['Other: Explicit Sensory Retraining for the lower extremities', 'Other: no treatment']}, {'type': 'OTHER', 'label': 'BA - early control usual care, later experimental treatment', 'description': 'BA - early control usual care, later experimental treatment', 'interventionNames': ['Other: Explicit Sensory Retraining for the lower extremities', 'Other: no treatment']}], 'interventions': [{'name': 'Explicit Sensory Retraining for the lower extremities', 'type': 'OTHER', 'description': 'Sensory retraining of detection, discrimination, quantification of a stimuli and recognition of stimuli and objects with the leg and mainly with the foot. Top-down awareness of bottom-up sensory experience in the treatment session and in everyday life.', 'armGroupLabels': ['AB - early experimental treatment, later control usual care', 'BA - early control usual care, later experimental treatment']}, {'name': 'no treatment', 'type': 'OTHER', 'description': 'Usual care', 'armGroupLabels': ['AB - early experimental treatment, later control usual care', 'BA - early control usual care, later experimental treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Asaph-Harofe Shamir Medical Center', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}], 'centralContacts': [{'name': 'Hadas Ofek, PT, PhD', 'role': 'CONTACT', 'email': 'hadasbarkolofek@gmail.com', 'phone': '+972544666412'}, {'name': 'Rotem Merose, MD', 'role': 'CONTACT', 'email': 'rotemme@shamir.gov.il'}]}, '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': 'MD', 'investigatorFullName': 'Rotem Merose', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}