Clinical trial NCT03465774: Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Official title: A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-14
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with MPE undergoing IPC placement

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.

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.

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

Primary outcomes:
measure: Time to pleural catheter removal
timeFrame: Up to 1 year
Secondary outcomes:
measure: Recurrence of effusion requiring drainage after IPC
timeFrame: Up to 1 year
measure: Indwelling pleural catheters (IPC) complications
timeFrame: Up to 1 year
measure: Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D)
timeFrame: Baseline up to 1 year
measure: Change in dyspnea using Borg score
timeFrame: Baseline up to 1 year
measure: Assessment of symptom burden
timeFrame: Baseline up to 1 year
measure: Procedure-associated pain
timeFrame: Up to 1 year
measure: Need for hospitalization due to pleurodesis pain
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Ost
role: PRINCIPAL_INVESTIGATOR
References: