Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT03422302
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of decrease in tumor motion', 'timeFrame': 'Up to 10 days', 'description': 'Paired t-test will be used to compare continuous positive airway pressure (CPAP) to deep inspiration breath hold (DIBH) in the decrease of tumor motion from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the decrease of tumor motion from free breathing with the adjustment of important demographic and clinical variables in the model.'}], 'secondaryOutcomes': [{'measure': 'Increase in lung volume', 'timeFrame': 'Up to 10 days', 'description': 'Increase in lung volume to be determined by using DIBH or CPAP from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the increase of lung volume from free breathing with the adjustment of important demographic and clinical variables in the model. The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables'}, {'measure': 'Assessment of time to deliver the planned radiation dose by using the most appropriate method', 'timeFrame': 'Up to 10 days', 'description': 'The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Carcinoma', 'Malignant Respiratory Tract Neoplasm', 'Metastatic Malignant Neoplasm in the Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the two methods of tumor motion management, continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) and to estimate the decrease in tumor motion from free breathing for CPAP and DIBH.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if CPAP is a more time-efficient option for tumor motion management than is DIBH.\n\nIa. Determine if CPAP is better tolerated by patients than is DIBH. Ib. Determine the reproducibility of lung expansion and tumor motion reduction by CPAP.\n\nIc. Determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with CPAP is comparable to that with DIBH.\n\nId. Measure treatment time differences between CPAP and breath hold (DIBH) treatments.\n\nOUTLINE:\n\nPatients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo biphasic positive airway pressure (BiPAP) CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.\n\nExclusion Criteria:\n\n* The patient has a contra-indication for using a CPAP device.\n* The patient has not signed a study-specific informed consent for this study.\n* The patient is uncooperative.\n* The patient has reduced consciousness.\n* The patient has sustained trauma or burns to the face.\n* The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.\n* The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.\n* Adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.'}, 'identificationModule': {'nctId': 'NCT03422302', 'briefTitle': 'Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Measuring the Effectiveness of a Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy (SBRT) for Tumors That Move With Respiration', 'orgStudyIdInfo': {'id': '2016-1105'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00884', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-1105', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)', 'description': 'Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.', 'interventionNames': ['Device: Biphasic Positive Airway Pressure', 'Procedure: Computed Tomography', 'Procedure: Continuous Positive Airway Pressure', 'Procedure: Deep Inspiration Breath Hold', 'Radiation: Radiation Therapy Treatment Planning and Simulation', 'Radiation: Stereotactic Body Radiation Therapy']}], 'interventions': [{'name': 'Biphasic Positive Airway Pressure', 'type': 'DEVICE', 'otherNames': ['BiPAP', 'Biphasic positive airway pressure (BiPAP)'], 'description': 'Receive BiPAP', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo CT simulation scans', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}, {'name': 'Continuous Positive Airway Pressure', 'type': 'PROCEDURE', 'otherNames': ['Continuous positive airway pressure (CPAP)', 'CPAP'], 'description': 'Receive CPAP', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}, {'name': 'Deep Inspiration Breath Hold', 'type': 'PROCEDURE', 'otherNames': ['DIBH'], 'description': 'Complete DIBH', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}, {'name': 'Radiation Therapy Treatment Planning and Simulation', 'type': 'RADIATION', 'otherNames': ['Radiation Therapy Treatment Planning/Simulation'], 'description': 'Undergo CT simulation scans', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}, {'name': 'Stereotactic Body Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['SABR', 'SBRT', 'Stereotactic Ablative Body Radiation Therapy'], 'description': 'Undergo SBRT', 'armGroupLabels': ['Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julianne M. Pollard, MD', 'role': 'CONTACT', 'phone': '713-563-2591'}, {'name': 'Julianne M. Pollard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Julianne M. Pollard, PHD', 'role': 'CONTACT', 'email': 'JMPollard@mdanderson.org', 'phone': '713-563-2591'}], 'overallOfficials': [{'name': 'Julianne M Pollard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}