{ "FullStudy":{ "Rank":217687, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518140", "OrgStudyIdInfo":{ "OrgStudyId":"2011-0689" }, "Organization":{ "OrgFullName":"M.D. Anderson Cancer Center", "OrgClass":"OTHER" }, "BriefTitle":"BiPAP-Vapotherm RCT", "OfficialTitle":"Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer" }, "StatusModule":{ "StatusVerifiedDate":"August 2013", "OverallStatus":"Withdrawn", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2013" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2019", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 12, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 13, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"M.D. Anderson Cancer Center", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.", "DetailedDescription":"Device A is designed to get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels.\n\nDevice B is designed to deliver air in and out of the lungs. The air is warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.\n\nDevice C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.\n\nStudy Groups and Device Use:\n\nIf you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:\n\nIf you are in Group 1, you will receive air through Device A for 1 hour, and then on an \"as needed\" basis for up to 4 hours. Then you will receive air through Device B for up to 30 minutes, followed by 30 minutes using Device C.\nIf you are in Group 2, you will receive air through Device B for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device C.\nIf you are in Group 3, you will receive air through Device C for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device B.\n\nThe study staff will help you use the devices. The maximum time allowed using the 3 devices is 6 hours total.\n\nDuring the \"as needed\" use period (4 hours), you will switch between the device you were assigned to and the same air delivery device and oxygen level that you were using just before you started the study.\n\nStudy Visit:\n\nDuring your study visit, the following tests and procedures will be performed:\n\nFrom your medical record, the study staff will collect information about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.\nYou will complete 2 questionnaires. The first asks about breathing symptoms, and the second asks about other symptoms you may be having. It should take about 15 minutes to complete these questionnaires.\nYour heart rate, breathing rate, and blood pressure will be recorded.\nThe level of air you breathe out will be recorded using a measuring device on your chest.\nBefore and after using the devices, you will be asked how hard it is to catch your breath and about any side effects you may be having.\nAt the end of the visit, you will fill out a questionnaire that asks about which device you prefer. It should take about 5 minutes to complete this questionnaire.\n\nLength of Study:\n\nYou will be on this study for up to 6 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.\n\nThis is an investigational study. The 3 breathing devices are commercially available and FDA approved for delivering oxygen when medically needed, including in cancer patients. It is investigational to collect information from patients to rate how well the study devices may affect shortness of breath.\n\nUp to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Advanced Cancers" ] }, "KeywordList":{ "Keyword":[ "Advanced Cancers", "Locally advanced", "Recurrent", "Metastatic disease", "Oxygen Delivery Modalities", "Shortness of breath", "Dyspnea", "VapoTherm", "Bilevel positive airway pressure", "BiPAP", "Non-rebreather mask" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"0", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"VapoTherm", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants receive air through VapoTherm for 1 hour, and then on an \"as needed\" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Oxygen Delivery Devices", "Behavioral: Questionnaires" ] } },{ "ArmGroupLabel":"BiPAP", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an \"as needed\" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Oxygen Delivery Devices", "Behavioral: Questionnaires" ] } },{ "ArmGroupLabel":"Non-Rebreather Mask", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants receive air through Non-Rebreather Mask for 1 hour, and then on an \"as needed\" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Oxygen Delivery Devices", "Behavioral: Questionnaires" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Oxygen Delivery Devices", "InterventionDescription":"Participants receive air through VapoTherm for 1 hour, and then on an \"as needed\" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BiPAP", "Non-Rebreather Mask", "VapoTherm" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Questionnaires", "InterventionDescription":"2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BiPAP", "Non-Rebreather Mask", "VapoTherm" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Surveys" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Efficacy of 3 Different Oxygen Delivery Methods", "PrimaryOutcomeDescription":"Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).", "PrimaryOutcomeTimeFrame":"6 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of advanced cancer, defined as locally advanced, recurrent, or metastatic disease\nPersistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >=3/10 on the numeric rating scale for at least 1 week and just prior to study initiation despite supplemental oxygen for at least 30 minutes\nDyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease\nInpatient at MD Anderson Cancer Center\nAble to communicate in English\nExpected life expectancy >1 week\nAge 18 or older\n\nExclusion Criteria:\n\nHypoxia (i.e., O2 saturation <90%) despite supplemental oxygen at 15 L/min\nHemodynamic instability (systemic blood pressure (SBP) <90 mmHg) within 1 hour of study initiation\nComatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher\nUncontrolled arrhythmia as per clinical record at enrollment\nUpper GI bleeding within 2 weeks of enrollment\nEsophageal rupture at enrollment\nUpper airway obstruction at enrollment\nHistory of facial trauma within 2 weeks of enrollment\nFacial, upper airway, or GI surgery within 2 weeks of enrollment\nThoracic surgery within 6 weeks of enrollment\nExcessive airway secretions interfering with BiPAP administration\nUndrained pneumothorax at enrollment\nPartial or complete small bowel obstruction or severe nausea/vomiting (Edmonton symptom assessment scale nausea >7/10) within 48 hours of enrollment\nHemoglobin <8 g/dL at the time of enrollment (blood drawn within past 2 weeks)\nAcute exacerbation of chronic obstructive pulmonary disease (COPD) or heart failure within 1 week of enrollment by history or physical\nKnown CO2 retainers as per clinic station\nKnown pulmonary hypertension as per clinic station\nUnwillingness to provide consent", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"David Hui, MD", "OverallOfficialAffiliation":"UT MD Anderson Cancer Center", "OverallOfficialRole":"Principal Investigator" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23739633", "ReferenceType":"derived", "ReferenceCitation":"Hui D, Morgado M, Chisholm G, Withers L, Nguyen Q, Finch C, Frisbee-Hume S, Bruera E. High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: a phase II randomized trial. J Pain Symptom Manage. 2013 Oct;46(4):463-73. doi: 10.1016/j.jpainsymman.2012.10.284. Epub 2013 Jun 2." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"UT MD Anderson Cancer Center Website", "SeeAlsoLinkURL":"http://www.mdanderson.org" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009369", "ConditionMeshTerm":"Neoplasms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6174", "ConditionBrowseLeafName":"Dyspnea", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" } ] } } } } } }