Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04558034
Status:
TERMINATED
Last Update Posted:
2021-03-08
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "There are 2 arms to the study.The Elasto-gel mitt and Rapid Relief slipper will be placed either on one hand/foot or both based on the patient's medical oncologist. All subjects will have a standardized onset/duration of therapy which includes the following :\n\n* 15 minutes prior to the paclitaxel infusion,\n* Continuously during the paclitaxel infusion,\n* 15 minutes after completion of paclitaxel for a total of 90 minutes."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Principal Investigator retired before study completed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbness,tingling,pain ,nail toxicities', 'timeFrame': '13 weeks', 'description': 'absence of numbness and tingling in the treated hands/feet\n\n* If there is an absence of pain in the treated hands/feet\n* If there is an absence of nail changes in the treated hands/feet'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cryotherapy Effect', 'Peripheral Neuropathy', 'Nail Toxicity']}, 'referencesModule': {'references': [{'pmid': '31559250', 'type': 'BACKGROUND', 'citation': 'Alessandrini A, Starace M, Cere G, Brandi N, Piraccini BM. 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St. Louis: Mosby.'}, {'pmid': '28586243', 'type': 'BACKGROUND', 'citation': 'Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.', 'detailedDescription': 'Women with breast cancer receiving paclitaxel will complete the Brief Pain Inventory(BPI), Neuropathic Pain Syndrome Inventory (NPSI)while a member of the research team will conduct an assessment of their nails. Once complete, cryotherapy will be administered 15 minutes prior to the paclitaxel infusion, continuously during and then 15 minutes after completion of the paclitaxel for a total of 90 minutes. Cyrotherapy will be delivered using Elasto-gel mitts and Rapid relief slippers. These items will be changed 45min after initiation to ensure coldness.\n\nThere will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females 18 or older\n* Histologically confirmed diagnosis of breast cancer\n* Receiving neo-adjuvant or adjuvant dose-dense anthracycline (AC) plus taxane-based chemotherapy or paclitaxel in combination with trastuzumab and pertuzumab\n\nExclusion Criteria:\n\n* Prior taxane therapy\n* Prior oxaliplatin therapy\n* Non-English speaking\n* History of peripheral neuropathy, i.e., Buerger's disease\n* History of diabetes mellitus\n* Pre-existing peripheral neuropathy from other conditions, e.g., Raynaud's disease, Guillain-Barre, Miller Fisher Syndrome\n* Hand, nail or foot conditions, e.g., hand/foot syndrome, arthritis, hammer toe, carpal tunnel, bunions, deformities\n* Alcohol abuse (history/current)\n* Current medication usage of opioids, anti-depressants, anti-convulsants, glutamines, vitamin B12"}, 'identificationModule': {'nctId': 'NCT04558034', 'briefTitle': 'The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Parkview Health'}, 'officialTitle': 'The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer', 'orgStudyIdInfo': {'id': 'NUR20-0124CRYO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interventioncryotherapy/control', 'description': 'Subjects will have one mitt/one slipper and serve as their own control', 'interventionNames': ['Other: cryotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'Subjects will have two mitts/slippers'}], 'interventions': [{'name': 'cryotherapy', 'type': 'OTHER', 'description': 'cryotherapy will be delivered', 'armGroupLabels': ['Interventioncryotherapy/control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46845', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Cancer Institute', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'Danielle R Payne, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parkview Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication and no end date', 'ipdSharing': 'YES', 'description': 'The following will be shared: Individual participant data that underlie the results reported in the planned article after deidentification including text,tables,figures, appendices', 'accessCriteria': 'Data will be available to anyone who wishes to access the data for any purpose by contacting nancy.ehmke@parkview.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parkview Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Danielle Payne', 'investigatorAffiliation': 'Parkview Health'}}}}