Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
Study NCT ID:
NCT02094950
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2014-03-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['concurrent chemotherapy', 'concurrent radiation'], 'conditions': ['Lung Cancer', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'This is a single arm clinical trial to establish the feasibility of conducting a clinical trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the completion of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Lung Cancer (Non small cell and small cell both eligible)\n* Completion of concurrent CRT at least 6 months prior to randomization.\n* Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)\n* Ability to understand written English -Willingness to adhere to all study-related procedures\n* Age 18 years old\n* ECOG Performance Status 1-3\n\nExclusion Criteria:\n\n* Current receipt of therapy for treatment related pneumonitis for 3 weeks.\n* Surgical resection of this LC (lobectomy or pneumonectomy)\n* Another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after CRT, untreated anemia with hemoglobin8 g/dL)\n* Current bleeding disorder by history\n* Life expectancy of 12 weeks, as assessed by primary oncologist'}, 'identificationModule': {'nctId': 'NCT02094950', 'briefTitle': 'Acupuncture Feasibility Trial for Dyspnea in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Acupuncture Feasibility Trial for Dyspnea in Lung Cancer', 'orgStudyIdInfo': {'id': 'UPCC 11513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung Cancer Patient with Dyspnea', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'armGroupLabels': ['Lung Cancer Patient with Dyspnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Joshua Bauml, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}