Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-02 @ 11:57 AM
Study NCT ID:
NCT07131618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chemotherapy-Induced Peripheral Neuropathy Assessment Tool', 'timeFrame': 'One week after each chemotherapy cycle (6 weeks total).', 'description': 'Change in peripheral neuropathy severity measured by the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) Scale range: 0 to 80 (higher scores indicate more severe neuropathy symptoms). Time Frame: One week after each weekly chemotherapy cycle, for six cycles (total 6 weeks).\n\nDescription: Peripheral neuropathy severity will be assessed using the CIPNAT scale, which evaluates sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores from all six cycles will be summed for analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecological cancer', 'cryocompression', 'peripheral neuropathy'], 'conditions': ['Gynecological Cancers', 'Peripheral Neuropathy Due to Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '9046355', 'type': 'BACKGROUND', 'citation': 'Molnar M, Rigo J Jr, Hertelendy F. Signal transduction in human myometrial cells. Acta Physiol Hung. 1996;84(2):89-97.'}, {'pmid': '15994152', 'type': 'BACKGROUND', 'citation': 'Scotte F, Tourani JM, Banu E, Peyromaure M, Levy E, Marsan S, Magherini E, Fabre-Guillevin E, Andrieu JM, Oudard S. Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol. 2005 Jul 1;23(19):4424-9. doi: 10.1200/JCO.2005.15.651.'}, {'pmid': '7447649', 'type': 'BACKGROUND', 'citation': 'Paprocka M, Budzynski W, Kusnierczyk H, Radzikowski C. Effect of cyclophosphamide on mouse bone marrow and leukemic stem cells. Arch Immunol Ther Exp (Warsz). 1980;28(3):447-51.'}, {'pmid': '6007752', 'type': 'BACKGROUND', 'citation': 'Hoki T. [The significance of limbal reaction for corneal antigen-antibody reaction]. Nihon Ganka Kiyo. 1966 Jul;17(7):721-31. No abstract available. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'Study Design:\n\nThis study is designed as a prospective, randomized controlled experimental study aiming to determine the effect of cryocompression therapy, applied during chemotherapy, on peripheral neuropathy symptoms in women with gynecologic cancers.\n\nResearch Hypotheses:\n\n* H₀: Cryocompression therapy has no effect on peripheral neuropathy.\n* H₁: Cryocompression therapy has an effect on peripheral neuropathy.\n\nStudy Population:\n\nThe study population will consist of women over the age of 18 living in Mersin, Türkiye, who are diagnosed with gynecologic cancer and undergoing chemotherapy between August 10 and December 31, 2025.', 'detailedDescription': 'This study will be conducted with women diagnosed with gynecological cancer who apply to the Oncology Outpatient Clinic and Ambulatory Chemotherapy Unit of Mersin University Hospital and voluntarily agree to participate in the research.\n\nThe sample size was calculated using the G\\*Power 3.1.9.7 program, based on the Chi-Square Test of Independence. In a previous study, the incidence of peripheral neuropathy was reported as 28.2% in the cold therapy group and 57.5% in the control group. Using these data, with a 5% margin of error (α = 0.05) and 80% power (1-β = 0.80), the required sample size was determined to be 35 participants per group. Considering potential data loss, the sample size in each group was increased by approximately 10%, resulting in 39 participants per group. A total of 78 participants will be included in the study.\n\nInclusion Criteria:\n\nAge 18 years or older,\n\nDiagnosed with gynecological cancer,\n\nReceiving weekly carboplatin-paclitaxel chemotherapy protocol,\n\nWilling to participate in the study and signing the informed consent form.\n\nIntervention:\n\nParticipants will be randomly assigned into two groups:\n\nIntervention Group: Cryocompression will be applied during chemotherapy using glove- and sock-shaped cryotherapy devices. The application will begin 15 minutes before the start of chemotherapy infusion, continue during chemotherapy administration, and last for an additional 15 minutes after infusion completion.\n\nControl Group: Standard chemotherapy treatment will be administered without any additional intervention.\n\nData Collection Process:\n\nAfter obtaining ethics committee approval, eligible women who meet the study criteria and agree to participate will be given verbal and written information about the study. The informed consent form will be included on the first page of the data collection tool. Those who sign the consent form will complete the questionnaire, which is expected to take approximately 10 minutes.\n\nStudy Timeline:\n\nParticipant recruitment will begin on August 10, 2025, and will be completed by December 31, 2025.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Applying to Mersin University Hospital Oncology Outpatient Clinic\n* Willing to participate and providing signed informed consent\n* Able to read and write in Turkish\n* Accessible and able to communicate\n* Citizen of the Republic of Türkiye\n* Diagnosed with gynecologic cancer (ovarian, endometrial, or cervical) and aged ≥18 years\n* Receiving weekly carboplatin + paclitaxel chemotherapy protocol\n* No subjective peripheral neuropathy symptoms before starting chemotherapy\n* No history of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols\n* No psychiatric disorders\n* No diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia\n\nExclusion Criteria:\n\n* Not applying to the specified outpatient clinic\n* No gynecologic cancer diagnosis or younger than 18 years old\n* Not providing informed consent\n* Not receiving weekly carboplatin + paclitaxel chemotherapy protocol\n* Presence of subjective peripheral neuropathy symptoms before starting chemotherapy\n* History of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols\n* Presence of psychiatric disorders\n* Having diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia'}, 'identificationModule': {'nctId': 'NCT07131618', 'acronym': 'CryoPN', 'briefTitle': 'The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer', 'orgStudyIdInfo': {'id': '2025/302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'interventionNames': ['Other: cryocompression']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'cryocompression', 'type': 'OTHER', 'description': 'Cryocompression induces vasoconstriction in the applied area, thereby reducing blood flow. As a result, the delivery of the chemotherapeutic agent to peripheral nerves is limited, and it is aimed to protect nerve tissue from toxic effects. At the same time, low temperature slows down nerve conduction and cellular metabolism, helping to prevent damage to nerve cells.\n\n30 minutes after the start of the paclitaxel infusion, cryocompression will be applied using ice gel gloves for the hands and socks for the feet, lasting 30 minutes. After paclitaxel ends, carboplatin will be infused intravenously in 250 cc isotonic solution over 1 hour. Cryocompression will again be applied 30 minutes after the start of the carboplatin infusion using the same method, for 30 minutes. This intervention will be performed weekly during each cycle of the 6-week carboplatin/paclitaxel protocol, for a total of 60 minutes per session.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'burcu okayer özer, MSc, PhD(c)', 'role': 'CONTACT', 'email': 'okayerb@gmail.com', 'phone': '+905530520077'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The IPD will be available within 6 months after publication of the primary results and will remain accessible for up to 5 years.', 'ipdSharing': 'YES', 'description': 'IPD Sharing Description: Individual participant data (IPD) will not be shared publicly. However, de-identified data may be shared with qualified researchers upon reasonable request, provided that appropriate ethical approvals are obtained.\n\nIPD Sharing Time Frame: Upon request, after the publication of the main results.\n\nIPD Sharing Access Criteria: Requests will be evaluated on a case-by-case basis and will be subject to institutional and ethics committee approval.\n\nIPD Sharing Supporting Information: The study protocol and statistical analysis plan may also be shared.', 'accessCriteria': 'Access will be granted to qualified researchers affiliated with academic or clinical institutions upon submission of a research proposal, signing of a data use agreement, and approval by the principal investigator and relevant ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, PhD(c), Registered Nurse', 'investigatorFullName': 'burcu okayer özer', 'investigatorAffiliation': 'Mersin University'}}}}