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Recruiting NCT03465774

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

— Observational Pleural Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline, Indwelling Catheter, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Pleural Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

Overview

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

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.

Interventions

  • Drug Doxycycline
    Receive via IPC
  • Device Indwelling Catheter
    Receive IPC
  • Procedure Quality-of-Life Assessment
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Time to pleural catheter removal [Time frame: Up to 1 year]
Secondary outcome measures (7)
  • Recurrence of effusion requiring drainage after IPC [Time frame: Up to 1 year]
  • Indwelling pleural catheters (IPC) complications [Time frame: Up to 1 year]
  • Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D) [Time frame: Baseline up to 1 year]
  • Change in dyspnea using Borg score [Time frame: Baseline up to 1 year]
  • Assessment of symptom burden [Time frame: Baseline up to 1 year]
  • Procedure-associated pain [Time frame: Up to 1 year]
  • Need for hospitalization due to pleurodesis pain [Time frame: Up to 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT03465774 · 2017-0973 · NCI-2018-00630 · 2017-0973

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗