Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-04-18 @ 1:52 AM
Study NCT ID:
NCT02150135
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2014-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-04', 'studyFirstSubmitDate': '2014-05-24', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECOG score change', 'timeFrame': '3 months after oncothermia treatment'}], 'secondaryOutcomes': [{'measure': 'Progression free survival rate', 'timeFrame': '3 months later after oncothermia treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'Quality of life', 'Pain'], 'conditions': ['Cancer, Pancreas']}, 'descriptionModule': {'briefSummary': 'Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient\'s body). However, there are several limitations in conventional hyperthermia. In this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inoperable or recurred pancreatic ductal adenocarcinoma\n* After the each cycle of chemotherapy, the disease status was "stable disease"\n\nExclusion Criteria:\n\n* Person who has an experience of hyperthermia treatment\n* Person who has a difficulty of sensing heat\n* Person who has a skin graft or breast reconstruction surgery\n* Person who has a cardiac pacemaker or an implanted metal\n* Pregnant or breast feeding women\n* Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months\n* Person who was treated with unproved drugs within 6 months\n* Person who have a serious disease which can affect the person\'s safety\n* Person who do not consent to the study'}, 'identificationModule': {'nctId': 'NCT02150135', 'briefTitle': 'Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'SNUBH-IMGPB-2014-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oncothermia group', 'description': 'Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.', 'interventionNames': ['Other: Oncothermia']}], 'interventions': [{'name': 'Oncothermia', 'type': 'OTHER', 'description': 'Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.', 'armGroupLabels': ['Oncothermia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jin-Hyeok Hwang, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospicare Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Hyeok Hwang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}