Recruiting

Indwelling Pleural Catheters & Doxycycline

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03465774

Conditions

Pleural Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline

Indwelling Catheter

Quality-of-Life Assessment

Questionnaire Administration

Survey Administration

Study Details

Brief summary:

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.

Conditions

Pleural Neoplasm

Study ID

NCT03465774

Start date

Mar 8, 2018

Status verified date

Mar, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

208 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 2 (IPC alone)

Patients undergo IPC placement.

Group I (IPC, doxycycline)

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

Interventions

Doxycycline

Receive via IPC

Indwelling Catheter

Receive IPC

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Time to pleural catheter removal [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

David Ost

713-792-6238dost@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David Ost

713-792-6238

Principal Investigator:

David Ost

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-05.