Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-24 @ 2:46 PM
Study NCT ID:
NCT04242927
Status:
UNKNOWN
Last Update Posted:
2020-04-01
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate of VEGFR inhibitor-associated hand-foot skin reaction', 'timeFrame': '2 year', 'description': 'Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).'}, {'measure': 'Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction', 'timeFrame': '2 year', 'description': 'Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.'}], 'secondaryOutcomes': [{'measure': 'Dose adjustment/withdrawal ratio', 'timeFrame': '2 year', 'description': 'Proportion of patients who need dose adjustment or withdrawal of VEGFR inhibitors, such as sorafenib, regorafenib, anlotinib, and apatinib.'}, {'measure': 'Hand-Foot Reaction Quality of Life (HF-QoL)', 'timeFrame': '2 year', 'description': 'Hand-Foot Reaction Quality of Life (HF-QoL) questionnaire, scoring results statistics. The HF-QoL symptom and daily activity total scores were transformed to a scale of 0 to 4, based on the sum of each unit-weighted item score divided by the maximum score. Higher scores on the HF-QoL indicate worse quality of life or greatersymptom burden.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand-Foot Skin Reaction (HFSR)']}, 'descriptionModule': {'briefSummary': 'Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting\n* HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE\n* Age from 18 to 75 years.\n* Life expectancy of at least 3 months at Day 1\n\nExclusion Criteria:\n\n* History of allergy to B vitamins\n* Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction\n* Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.\n* History of psychiatric drugs substance abuse and fails to quit it or has amental disorder\n* Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception'}, 'identificationModule': {'nctId': 'NCT04242927', 'briefTitle': 'A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial', 'orgStudyIdInfo': {'id': 'NAVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinic acid + Routine care', 'description': 'Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.', 'interventionNames': ['Drug: Nicotinic acid +Routine care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care', 'description': 'Routinely apply urea ointment and provide best supportive care.', 'interventionNames': ['Drug: Routine care']}], 'interventions': [{'name': 'Nicotinic acid +Routine care', 'type': 'DRUG', 'otherNames': ['Nicotinic Acid 50 MG Oral Tablet'], 'description': 'Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.', 'armGroupLabels': ['Nicotinic acid + Routine care']}, {'name': 'Routine care', 'type': 'DRUG', 'otherNames': ['Urea ointment'], 'description': 'Routinely apply urea ointment and provide best supportive care.', 'armGroupLabels': ['Routine care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqin Chen', 'role': 'CONTACT', 'email': 'chenlucy1437@aliyun.com', 'phone': '+8613735430109'}, {'name': 'Xueqin Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shenglin Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "First People's Hospital of Hangzhou", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xueqin Chen, MD', 'role': 'CONTACT', 'email': 'chenlucy1437@aliyun.com', 'phone': '+8613735430109'}, {'name': 'Shenglin Ma, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Shenglin Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}