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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03465774
Other study ID # 2017-0973
Secondary ID NCI-2018-0063020
Status Recruiting
Phase
First received
Last updated
Start date March 8, 2018
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source M.D. Anderson Cancer Center
Contact David Ost
Phone 713-792-6238
Email dost@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 208
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Doxycycline
Receive via IPC
Device:
Indwelling Catheter
Receive IPC
Procedure:
Quality-of-Life Assessment
Ancillary studies
Other:
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Recurrence of effusion requiring drainage after IPC Up to 1 year
Secondary Indwelling pleural catheters (IPC) complications Up to 1 year
Secondary Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D) Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement. Baseline up to 1 year
Secondary 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
Secondary Assessment of symptom burden Baseline up to 1 year
Secondary Procedure-associated pain Up to 1 year
Secondary Need for hospitalization due to pleurodesis pain Up to 1 year
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