Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-01 @ 5:45 AM
Study NCT ID:
NCT06934733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer
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': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)', 'timeFrame': 'From the start of TROP2-ADC treatment to the 8th week', 'description': 'The incidence and severity of oral mucositis at week 8'}], 'secondaryOutcomes': [{'measure': 'The incidence and severity of oral mucositis at week 12 and week 24', 'timeFrame': 'From the start of TROP2-ADC treatment to the 12th and 24th week', 'description': 'The incidence and severity of oral mucositis at week 12and week 24'}, {'measure': 'Progression-free survival(PFS)', 'timeFrame': 'Up to approximately 28 weeks', 'description': 'The Time from randomization to tumor progression or death due to any cause'}, {'measure': 'Treatment interruption rate', 'timeFrame': 'Up to approximately 28 weeks', 'description': 'Time from the initial administration of TROP2-ADC to treatment interruption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.\n2. Age ≥ 18 years at the time of informed consent signing.\n3. Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.\n4. ECOG PS: 0-2 points;\n5. The expected survival time was more than 3 months;\n6. Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:\n\n 1. Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L\n 2. Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.\n 3. Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).\n 4. Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.\n7. Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.\n8. Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Prior TROP2-targeted treatment was administered.\n2. Patients with active oral mucositis or oral ulcers were excluded.\n3. Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.\n4. Other conditions where the investigator determines the patient is unsuitable for study participation.'}, 'identificationModule': {'nctId': 'NCT06934733', 'briefTitle': 'The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer: A Randomized, Controlled, Multicenter Clinical Study', 'orgStudyIdInfo': {'id': 'HNCH-MBC17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral cryotherapy', 'interventionNames': ['Other: Oral cryotherapy']}, {'type': 'OTHER', 'label': 'Routine oral care', 'interventionNames': ['Other: Routine oral care']}], 'interventions': [{'name': 'Oral cryotherapy', 'type': 'OTHER', 'description': 'Patients randomly assigned to the experimental group underwent TROP2-ADC treatment. They continuously held ice cubes and ice water from 15 minutes before the infusion, throughout the infusion process, and for 15 minutes after the infusion. Ice cubes were promptly replaced with fresh ones as they melted. Patients were instructed not to consume any food or liquids orally for 1 hour following the completion of the ice therapy.', 'armGroupLabels': ['Oral cryotherapy']}, {'name': 'Routine oral care', 'type': 'OTHER', 'description': 'Patients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care.', 'armGroupLabels': ['Routine oral care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Min Yan', 'role': 'CONTACT', 'email': 'ym200678@126.com', 'phone': '+86 15713857388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}