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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00630 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0973 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 (IPC alone) | Patients undergo IPC placement. |
| |
| Group I (IPC, doxycycline) | Patients undergo IPC placement and receive doxycycline via IPC 5 days later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Receive via IPC |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Time to pleural catheter removal | 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatients with MPE undergoing IPC placement
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Ost | Contact | 713-792-6238 | dost@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| David Ost | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Indwelling Catheter | Device | Receive IPC |
|
| Quality-of-Life Assessment | Procedure | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement. |
| Baseline up to 1 year |
| Change in dyspnea using Borg score | 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. | Baseline up to 1 year |
| 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 |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002408 | Catheters, Indwelling |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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