Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 6:36 AM
Study NCT ID:
NCT07112950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the participants and the outcome assessors will be blinded to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Press needle acupuncture and standart therapy will be designated as the intervention group, while the sham press needle acupucnture and standart therapy will be designated as the control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) for Pain', 'timeFrame': 'Before therapy, Day 1, Day 3, Day 7, and Day 14', 'description': 'Pain intensity will be measured using the Visual Analogue Scale (VAS), which consists of a horizontal or vertical line 10 cm (100 mm) in length, representing a continuum of pain intensity from:\n\n0 = No pain at all\n\n10 = Worst imaginable pain'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy - Lung (FACT-L)', 'timeFrame': 'Before therapy, Day 7, and Day 14', 'description': 'Quality of life will be assessed using the FACT-L questionnaire, consisting of 37 items rated on a 0-4 Likert scale:\n\n0 = Not at all\n\n1. = A little bit\n2. = Somewhat\n3. = Quite a bit\n4. = Very much\n\nTotal scores range from 0 to 28 (higher scores indicate better quality of life).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.\n\nThe main question this study aims to answer is:\n\nDoes press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?\n\nResearchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.\n\nParticipants will:\n\nReceive either press needle acupuncture or sham press needle acupuncture for 7 days\n\nVisit the clinic once a week for examination and evaluation\n\nRecord improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.\n* Lung cancer patients aged over 18 years.\n* Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).\n* Patients with a VAS score \\>10 mm for baseline pain and \\>40 mm during breakthrough pain.\n* Willing to participate in the study until completion by signing the informed consent form.\n\nExclusion Criteria:\n\n* Lung cancer patients with deteriorating general condition.\n* Presence of wounds or infections at the press needle insertion site.\n* History of allergy to stainless steel materials.\n* Patients with blood clotting disorders: platelet count \\<50,000/μL, ANC \\<1000/mm³, or patients undergoing anticoagulant therapy with INR \\>2.142.'}, 'identificationModule': {'nctId': 'NCT07112950', 'briefTitle': 'Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients', 'orgStudyIdInfo': {'id': '25-05-0758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The press needle acupuncture and standart therapy', 'interventionNames': ['Device: Press Needle Acupuncture and standart therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'The sham press needle acupuncture and standart therapy', 'interventionNames': ['Device: Press Needle Acupuncture and standart therapy']}], 'interventions': [{'name': 'Press Needle Acupuncture and standart therapy', 'type': 'DEVICE', 'description': 'The patient will have a press needle applied, which will be removed on the seventh day.', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'contacts': [{'name': 'Yuanti Yunus Konda, MD', 'role': 'CONTACT', 'email': 'yuanti.yunus@ui.ac.id', 'phone': '+6285240864987'}], 'facility': 'Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Yuanti Yunus Konda, MD', 'role': 'CONTACT', 'email': 'yuanti.yunus@ui.ac.id', 'phone': '+6285240864987'}], 'overallOfficials': [{'name': 'KPEK FKUI-RSCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Health Research Ethics Commitee of Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yuanti Yunus Konda', 'investigatorAffiliation': 'Indonesia University'}}}}