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

NCT03465774 | Recruiting FDA Drug

• 2 other identifiers: 2017-0973NCI-2018-00630
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Change in dyspnea using Borg score

  Baseline up to 1 year

• Assessment of symptom burden

  Baseline up to 1 year

Study Arms (2)

Group 2 (IPC alone)

Patients undergo IPC placement.

Device: Indwelling Catheter; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

Group I (IPC, doxycycline)

Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Drug: Doxycycline; Device: Indwelling Catheter; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Doxycycline DRUG

Receive via IPC

Also known as: Doxycycline Monohydrate

Group I (IPC, doxycycline)

Indwelling Catheter DEVICE

Receive IPC

Group 2 (IPC alone); Group I (IPC, doxycycline)

Questionnaire Administration OTHER

Ancillary studies

Group 2 (IPC alone); Group I (IPC, doxycycline)

Survey Administration OTHER

Ancillary studies

Group 2 (IPC alone); Group I (IPC, doxycycline)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Group 2 (IPC alone); Group I (IPC, doxycycline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with MPE undergoing IPC placement

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pleural Neoplasms

Interventions

Doxycycline; Catheters, Indwelling

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Catheters; Equipment and Supplies

Study Officials

• David Ost

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Ost

CONTACT

713-792-6238; dost@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: March 8, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)