[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03465774":3,"trial-entities:NCT03465774":126,"trial-summary:NCT03465774":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":55,"secondary_outcomes":60,"sex":78,"minimum_age":79,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":96,"locations":99,"central_contacts":116,"overall_officials":119,"references":121,"see_also_links":122},"NCT03465774","2017-0973","Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions","A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions","RECRUITING","2028-12-01","2026-03","2026-03-05","2018-03-08","M.D. Anderson Cancer Center","OTHER",false,"This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.","PRIMARY OBJECTIVES:\n\nI. To obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE).\n\nOUTLINE: Patients choose 1 of 2 groups.\n\nGROUP I: Patients undergo IPC placement and receive doxycycline via IPC 5 days later.\n\nGROUP II: Patients undergo IPC placement.\n\nAfter completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.",[19],"Pleural Neoplasm",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},208,"ESTIMATED",[28,36,42,49,52],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Doxycycline","Receive via IPC",[33],"Group I (IPC, doxycycline)",[35],"Doxycycline Monohydrate",{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Indwelling Catheter","Receive IPC",[41,33],"Group 2 (IPC alone)",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"PROCEDURE","Quality-of-Life Assessment","Ancillary studies",[41,33],[48],"Quality of Life Assessment",{"type":14,"name":50,"description":45,"armGroupLabels":51},"Questionnaire Administration",[41,33],{"type":14,"name":53,"description":45,"armGroupLabels":54},"Survey Administration",[41,33],[56],{"measure":57,"description":58,"timeFrame":59},"Time to pleural catheter removal","This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal.","Up to 1 year",[61,63,65,69,72,74,76],{"measure":62,"timeFrame":59},"Recurrence of effusion requiring drainage after IPC",{"measure":64,"timeFrame":59},"Indwelling pleural catheters (IPC) complications",{"measure":66,"description":67,"timeFrame":68},"Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D)","Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement.","Baseline up to 1 year",{"measure":70,"description":71,"timeFrame":68},"Change in dyspnea using Borg score","Will use paired t-test to compare baseline and 1 month Borg scores and utilities. A generalized linear model will be used to evaluate whether other variables have any impact on the pairwise differences between baseline and 1 month.",{"measure":73,"timeFrame":68},"Assessment of symptom burden",{"measure":75,"timeFrame":59},"Procedure-associated pain",{"measure":77,"timeFrame":59},"Need for hospitalization due to pleurodesis pain","ALL","18 Years",{"inclusion":81,"exclusion":85,"raw_text":95},[82,83,84],"Outpatients with MPE undergoing IPC placement","Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions","Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter",[86,87,88,89,90,91,92,93,94],"Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)","Inability or unwillingness to give informed consent","Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)","Pregnancy","Previous intrapleural therapy for MPE on the same side","Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =\\\u003C 2 weeks","Doxycycline allergy","Extensive loculations or hydropneumothorax or other contraindication to pleurodesis","Chylous effusions associated with malignant disease","Inclusion Criteria:\n\n* Outpatients with MPE undergoing IPC placement\n* Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions\n* Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter\n\nExclusion Criteria:\n\n* Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)\n* Inability or unwillingness to give informed consent\n* Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)\n* Pregnancy\n* Previous intrapleural therapy for MPE on the same side\n* Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =\\\u003C 2 weeks\n* Doxycycline allergy\n* Extensive loculations or hydropneumothorax or other contraindication to pleurodesis\n* Chylous effusions associated with malignant disease",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":113},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[107,111],{"name":108,"role":109,"phone":110},"David Ost","CONTACT","713-792-6238",{"name":108,"role":112},"PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},29.76328,-95.36327,[117],{"name":108,"role":109,"phone":110,"email":118},"dost@mdanderson.org",[120],{"name":108,"affiliation":13,"role":112},[],[123],{"label":124,"url":125},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":127,"biomarkers":128},[19],[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an observational study, meaning participants choose one of two groups: IPC alone or IPC with doxycycline. It aims to enroll 208 participants.","completed","Indwelling Pleural Catheters With or Without Doxycycline for Malignant Pleural Effusions","This study is looking at how well indwelling pleural catheters (IPCs), which are tubes placed to drain fluid from around the lungs, work to treat malignant pleural effusions (MPE), which is fluid buildup caused by cancer. It compares using IPCs alone versus using IPCs with doxycycline, an antibiotic that can also help reduce fluid buildup. The main goal is to see if adding doxycycline can shorten the time you need to have the IPC in place. You may be able to join if you are an outpatient getting an IPC or an inpatient expected to go home soon after getting one. The study is currently observing patients, and aims to enroll 208 participants.","Participants are followed up at 10-14 days and then monthly for up to a year after treatment.",113,"You will receive an indwelling pleural catheter. If you are in Group I, you will also receive doxycycline via the IPC 5 days later. You will have follow-up visits at 10-14 days and then monthly for up to a year.","Not stated in the trial record.",[30],"v2"]