Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00530205
Status:
WITHDRAWN
Last Update Posted:
2011-07-14
First Post:
2007-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy and protein consumption measured on an average radiotherapy treatment day by multiple pass method 24-hour analysis for food recall at baseline and treatment end'}, {'measure': 'Comparison of energy and protein by mouth intake from baseline to treatment end'}, {'measure': 'Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end'}, {'measure': 'Lean body mass versus fat mass using a bioelectrical impedance analysis machine'}, {'measure': 'Comparison of body fat to lean body mass percentage at baseline and at treatment end'}, {'measure': 'Correlation of energy and protein consumption with lean body mass at baseline and treatment end'}, {'measure': 'Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment'}, {'measure': 'Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weight changes', 'malnutrition', 'stage III non-small cell lung cancer'], 'conditions': ['Lung Cancer', 'Malnutrition', 'Weight Changes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/results?term=case5506', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment.\n\nPURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* To determine energy and protein consumption on an average radiotherapy treatment day using the multiple pass method 24-hour analysis of food recall at baseline and treatment end.\n* To compare energy and protein by mouth intake from baseline to treatment end.\n* To measure and compare diet quality from baseline to radiotherapy treatment end by Healthy Eating Index (HEI) score.\n* To determine lean body mass versus fat mass using a bioelectrical impedance analysis machine.\n* To compare body fat to lean body mass percentage at baseline with that at radiotherapy treatment end.\n* To correlate energy and protein consumption with lean body mass at baseline and treatment end.\n* To determine the change in appetite throughout radiotherapy by comparing data obtained by interview at baseline and radiotherapy treatment end.\n* To determine the change in performance level (Karnofsky percentage) associated with the radiotherapy through a series of questions asked at baseline and treatment end.\n\nOUTLINE: Patients receive radiotherapy as planned for 7 weeks. Patients undergo an interview on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after completion of radiotherapy) regarding recent food consumption history and appetite. Patients' standing weight and height are measured on these days and their body composition, measured with a bioelectrical impedance analysis (BIA) device, are also taken. Patients' Karnofsky performance score are obtained from their medical record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care center', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with stage III non-small cell lung cancer (NSCLC)\n* Plan to begin radiotherapy for NSCLC\n\n * Radiotherapy is the only planned therapy for this cancer\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* Must be able to stand without assistance\n\nExclusion criteria:\n\n* Unable to comply with study requirements\n* Native language other than American English\n* Pacemaker or implanted defibrillator\n\nPRIOR CONCURRENT THERAPY:\n\nExclusion criteria:\n\n* Receiving chemotherapy in combination with radiotherapy\n* Concurrent megace or steroids'}, 'identificationModule': {'nctId': 'NCT00530205', 'briefTitle': 'Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment', 'orgStudyIdInfo': {'id': 'CASE5506'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE5506', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'CASE-5506-CC217'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'physiologic testing', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jessica Stauffer, BS', 'role': 'STUDY_CHAIR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Jessica Stauffer', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}