RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-03-08
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03465774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Outpatients with MPE undergoing IPC placement
  2. * Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions
  3. * Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter
  1. * Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
  2. * Inability or unwillingness to give informed consent
  3. * Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
  4. * Pregnancy
  5. * Previous intrapleural therapy for MPE on the same side
  6. * Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =\< 2 weeks
  7. * Doxycycline allergy
  8. * Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
  9. * Chylous effusions associated with malignant disease

Contacts and Locations

Study Contact

David Ost
CONTACT
713-792-6238
dost@mdanderson.org

Principal Investigator

David Ost
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • David Ost, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-08
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2018-03-08
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pleural Neoplasm