Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06352567
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2024-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symptoms Associated with 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms', 'timeFrame': 'From completion of systemic chemotherapy up to two months', 'description': 'European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire was used to assess symtomps associated with CIPN. Higher scores indicate worse, or vice versa. Minimum and maximum score are 0 and 100, respectively. The questionnaire is calculated in three different sub-domains as follows: Autonomic, sensory and motor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Neuropathy', 'Chemotherapeutic Toxicity', 'Chemotherapy-induced Peripheral Neuropathy'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy', 'Breast Cancer', 'Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '37838686', 'type': 'BACKGROUND', 'citation': 'Tugral A, Aribas Z, Akyol M, Bakar Y. Assessment of sensorimotor and strength related function of breast cancer patients during systemic drug therapy: a prospective observational study. BMC Cancer. 2023 Oct 14;23(1):981. doi: 10.1186/s12885-023-11494-x.'}, {'pmid': '25261162', 'type': 'BACKGROUND', 'citation': 'Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.'}, {'pmid': '31456070', 'type': 'BACKGROUND', 'citation': 'Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.'}, {'pmid': '37702983', 'type': 'BACKGROUND', 'citation': 'Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13.'}, {'pmid': '28204996', 'type': 'BACKGROUND', 'citation': 'Song SJ, Min J, Suh SY, Jung SH, Hahn HJ, Im SA, Lee JY. Incidence of taxane-induced peripheral neuropathy receiving treatment and prescription patterns in patients with breast cancer. Support Care Cancer. 2017 Jul;25(7):2241-2248. doi: 10.1007/s00520-017-3631-x. Epub 2017 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).', 'detailedDescription': "Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within 1-2 months after completion of systemic chemotherapy. A simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. In addition, the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area (BSA) and DuBois formulation as follows: BSA \\[m2\\] = Weight \\[kg\\]0.425 × height (cm)0.725 × 0.007184\\]. The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: Four cycles of Anthracycline were applied 14 days apart 60 mg/m2 intravenous (IV), 12 cycles of Paclitaxel were applied seven days apart 80 mg/m2 IV, and four cycles of Docetaxel were applied 21 days apart 75 mg/m2 IV."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with breast cancer and referred to the medical oncology unit for the purpose of systemic chemotherapy treatment were screened and invited to participate in this study.', 'genderDescription': 'Being female.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a volunteer to participate\n* aged over 18 years old\n* being female\n* being a candidate for systemic chemotherapy\n\nExclusion Criteria:\n\n* Having distant metastasis\n* Having comorbidities that might contribute to or cause sensorial and motor deficits such as multiple sclerosis, diabetes, polyneuropathy, etc.,\n* Prolonged surgical (if any) complications (i.e. pain, seroma, etc.)'}, 'identificationModule': {'nctId': 'NCT06352567', 'briefTitle': 'Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Bakircay University'}, 'officialTitle': 'A View of Perceived Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer', 'orgStudyIdInfo': {'id': 'BakircayU1394/1414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer', 'description': 'Patients diagnosed with breast cancer who underwent systemic adjuvant or neoadjuvant chemotherapy will be assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within completion of the systemic chemotherapy in 1-2 months.', 'interventionNames': ['Other: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire']}], 'interventions': [{'name': 'European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire', 'type': 'OTHER', 'description': 'It consists of a total of 20 items each is scored from "1: not at all" to "4: very much" in a 4-point Likert scale. Individuals are requested to fill out by considering their last week. Sensory, motor, and autonomic subscales are reported within its constructs. A total of 9, 8, and 3 items are referred to as sensory, motor, and autonomic disturbances, respectively', 'armGroupLabels': ['Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35620', 'city': 'Izmir', 'state': 'Çiğli', 'country': 'Turkey (Türkiye)', 'facility': 'Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Alper Tuğral, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Bakircay University'}, {'name': 'Murat Akyol, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmir Bakircay University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Bakircay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alper Tuğral', 'investigatorAffiliation': 'Izmir Bakircay University'}}}}