Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
NCT ID: NCT03465774
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
208 participants
OBSERVATIONAL
2018-03-08
2028-12-01
Brief Summary
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Detailed Description
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I. To obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE).
OUTLINE: Patients choose 1 of 2 groups.
GROUP I: Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
GROUP II: Patients undergo IPC placement.
After completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 2 (IPC alone)
Patients undergo IPC placement.
Indwelling Catheter
Receive IPC
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Group I (IPC, doxycycline)
Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Doxycycline
Receive via IPC
Indwelling Catheter
Receive IPC
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Doxycycline
Receive via IPC
Indwelling Catheter
Receive IPC
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 =\< 2 weeks
* Doxycycline allergy
* Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
* Chylous effusions associated with malignant disease
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Ost
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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David Ost
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-00630
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0973
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0973
Identifier Type: -
Identifier Source: org_study_id
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