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

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Procedure: Quality-of-Life Assessment; Device: Indwelling Catheter; Drug: Doxycycline

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 208

Contacts and Locations

• Study Contact: Name: David Ost; Phone Number: 713-792-6238; Email: dost@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: David Ost; Phone Number: 713-792-6238
      • Principal Investigator: David Ost

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Outpatients with MPE undergoing IPC placement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 2 (IPC alone); Patients undergo IPC placement.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Device: Indwelling Catheter; Receive IPC
Group I (IPC, doxycycline); Patients undergo IPC placement and receive doxycycline via IPC 5 days later.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Device: Indwelling Catheter; Receive IPC; Drug: Doxycycline; Receive via IPC; Other Names: Doxycycline Monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of effusion requiring drainage after IPC		Up to 1 year
Indwelling pleural catheters (IPC) complications		Up to 1 year
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
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.	Baseline up to 1 year
Assessment of symptom burden		Baseline up to 1 year
Procedure-associated pain		Up to 1 year
Need for hospitalization due to pleurodesis pain		Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David Ost, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Pleural Neoplasms; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 2017-0973 (Other Identifier: M D Anderson Cancer Center); NCI-2018-00630 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No