Pleural Neoplasm
Conditions
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.
Interventions
DRUGDoxycycline
Receive via IPC
DEVICEIndwelling Catheter
Receive IPC
PROCEDUREQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to pleural catheter removal | Up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline up to 1 year | Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement. |
| Change in dyspnea using Borg score | Baseline up to 1 year | 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. |
| 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 | — |
Countries
United States
Contacts
CONTACTDavid Ost
PRINCIPAL_INVESTIGATORDavid Ost
M.D. Anderson Cancer Center
Outcome results
None listed