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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03465774
Collaborator
National Cancer Institute (NCI) (NIH)
208
Enrollment
1
Location
45.8
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Doxycycline
  • Device: Indwelling Catheter
  • Procedure: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
208 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
Actual Study Start Date :
Mar 8, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Group 2 (IPC alone)

Patients undergo IPC placement.

Device: Indwelling Catheter
Receive IPC

Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Survey Administration
    Ancillary studies

    Group I (IPC, doxycycline)

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

    Drug: Doxycycline
    Receive via IPC
    Other Names:
  • Doxycycline Monohydrate
  • Device: Indwelling Catheter
    Receive IPC

    Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Recurrence of effusion requiring drainage after IPC [Up to 1 year]

    2. Indwelling pleural catheters (IPC) complications [Up to 1 year]

    3. 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.

    4. 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.

    5. Assessment of symptom burden [Baseline up to 1 year]

    6. Procedure-associated pain [Up to 1 year]

    7. Need for hospitalization due to pleurodesis pain [Up to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1M D Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: David Ost, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03465774
    Other Study ID Numbers:
    • 2017-0973
    • NCI-2018-00630
    • 2017-0973
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Nov 16, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2020