Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06964802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled prospective study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To prevent the development of chemotherapy-associated peripheral neuropathy in patients', 'timeFrame': 'This was at the end of the 12th week of paclitaxel treatment.', 'description': "Patients who respond 'No' to part A of the CIPNAT scale and who do not respond to the monofilament and vibration tests will be considered free of chemotherapy-related peripheral neuropathy."}], 'secondaryOutcomes': [{'measure': 'If you are experiencing chemotherapy-related peripheral neuropathy, the symptoms should be mild, occur less frequently and have a minimal impact on your daily life and activities.', 'timeFrame': 'This was at the end of the 12th week of paclitaxel treatment.', 'description': 'A score close to 0 on the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) scale, which ranges from 0 to 140, and a grade close to 1 on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale, which grades from 1 to 5.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemotherapy-Induced Peripheral Neuropathy', 'Cold Salt Water', 'Foot Bath', 'Breast Cancer', 'Paclitaxel'], 'conditions': ['Breast Cancer Patients', 'Chemotherapy Induced Peripheral Neuropathy (CIPN)', 'Paclitaxel-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': "This prospective, randomised, controlled study was designed to evaluate the effectiveness of salt and unsalted cold water foot baths in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving paclitaxel. The study's sub-objectives were to minimise the development of CIPN, reduce its severity and incidence of symptoms, and minimise its impact on daily life and activities.\n\nHypothesis(es):\n\nH1: Salt cold water foot bath affects the development of chemotherapy-induced peripheral neuropathy.\n\nH2: There is an effect of unsalted cold water foot bath on the development of chemotherapy-induced peripheral neuropathy.\n\nH3: The effects of salt and unsalted cold water foot baths on the development of chemotherapy-induced peripheral neuropathy.\n\nH4: Salt and unsalted cold water foot baths are more effective than standard clinical care in the development of chemotherapy-induced peripheral neuropathy.\n\nResearchers will compare the salt cold water with the unsalted cold water, unsalted cold water and control group to determine whether the salt cold water has an effect on CIPN.\n\nThe experimental group and active comparator participants will continue the application for 12 cycles (12 weeks) of paclitaxel. The application will be applied by researcher Tuba Eryiğit. In addition, before each application for 12 weeks, the severity of CIPN, its effect on daily life and grade will be evaluated.\n\nThe control group will continue clinical routine care applications for 12 cycles (12 weeks). In addition, the severity of CIPN, its effect on daily life and grade will be evaluated before each treatment in the same way as the experimental groups."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 18 and over.\n* Conscious\n* Speaking and understanding Turkish\n* The diagnosis was breast cancer\n* Those who will receive paclitaxel chemotherapy\n* These are patients who answered 'no' to the 'A' section of the CIPNAT scale\n\nExclusion Criteria:\n\n* Responding to the vibration test (if the practitioner does not feel the vibration when the patient says they feel the vibration, it means that neuropathy is present)\n* Feeling pressure in one or none of the three areas on the plantar surface of the foot according to the monofilament test\n* Previous chemotherapy-associated peripheral neuropathy\n* Diagnosed with diabetes\n* Open wounds or skin ulcers on the foot\n* With peripheral and central nervous system disease\n* Peripheral vascular disease,\n* Patients with bone or soft tissue metastases"}, 'identificationModule': {'nctId': 'NCT06964802', 'briefTitle': 'The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Topkapi University'}, 'officialTitle': 'The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'IstanbulTopkapiU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Cold salt water foot bath group)', 'description': 'During the three hours of paclitaxel treatment, 30 minutes of salt cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of salt cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.', 'interventionNames': ['Other: Cold salt water foot bath']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Cold unsalted water foot bath group)', 'description': 'During the three hours of paclitaxel treatment, 30 minutes unsalted cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of unsalted cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.', 'interventionNames': ['Other: Cold water foot bath']}, {'type': 'NO_INTERVENTION', 'label': 'Group C (control group)', 'description': 'Patients in this group will be given general information about the care guidelines for chemotherapy patients at the clinic where they receive treatment. This information will be provided once. At the end of the study, patients in the control group will be offered a choice of two application methods, and the method they choose will be applied to them in the same way as to Groups A and B.\n\nGroup C patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before each chemotherapy cycle at the same time with Group A and B patients. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.'}], 'interventions': [{'name': 'Cold salt water foot bath', 'type': 'OTHER', 'description': 'The application of 175 grams of salt to cold water at a constant 22 degrees', 'armGroupLabels': ['Group A (Cold salt water foot bath group)']}, {'name': 'Cold water foot bath', 'type': 'OTHER', 'description': 'Constant 22 degree cold water application', 'armGroupLabels': ['Group B (Cold unsalted water foot bath group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Uskudar', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Caglar Unal, Associate professor', 'role': 'CONTACT', 'email': 'caglarunal5@gmail.com', 'phone': '+90 544 689 41 39'}, {'name': 'Tuba Eryigit, PhD student', 'role': 'CONTACT', 'email': 'tubaeryigit@topkapi.edu.tr', 'phone': '+90 0505 968 33 32'}, {'name': 'Caglar Unal, Associate professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tuba Eryigit, PhD student/Specialist nurse', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ayse Ozkaraman, Prof./Thesis supervisor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Haydarpaşa Numune Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tuba Eryigit, PhD student', 'role': 'CONTACT', 'email': 'tubaeryigit@topkapi.edu.tr', 'phone': '+905059683332'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participant responses and personal information will be used for scientific purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuba Eryiğit', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research assistant/Specialist nurse', 'investigatorFullName': 'Tuba Eryiğit', 'investigatorAffiliation': 'Istanbul Topkapi University'}}}}