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NCT03465774 | RECRUITING | Pleural Neoplasm

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

M.D. Anderson Cancer Center

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.

Condition or disease

Pleural Neoplasm

Intervention/treatment

Doxycycline

Indwelling Catheter

Quality-of-Life Assessment

Questionnaire Administration

Survey Administration

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
Estimated Enrollment : 208 participants
Official Title : A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
Actual Study Start Date : 2018-03-08
Estimated Primary Completion Date : 2025-04-30
Estimated Study Completion Date : 2025-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions

Location Details

NCT03465774

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030