Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions

NCT ID: NCT03465774

Last Updated: 2025-09-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-08

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

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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Pleural Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 2 (IPC alone)

Patients undergo IPC placement.

Indwelling Catheter

Intervention Type DEVICE

Receive IPC

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Group I (IPC, doxycycline)

Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Doxycycline

Intervention Type DRUG

Receive via IPC

Indwelling Catheter

Intervention Type DEVICE

Receive IPC

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Doxycycline

Receive via IPC

Intervention Type DRUG

Indwelling Catheter

Receive IPC

Intervention Type DEVICE

Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Doxycycline Monohydrate Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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 =\< 2 weeks
* Doxycycline allergy
* Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
* Chylous effusions associated with malignant disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Ost

Role: CONTACT

713-792-6238

Facility Contacts

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David Ost

Role: primary

713-792-6238

Related Links

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http://www.mdanderson.org

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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