Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 25 for:    "Pleural Disease" | "Anti-Bacterial Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465774
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating patients with malignant pleural effusions. These types of catheters 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. It is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating patients with cancerous pleural effusions.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Drug: Doxycycline Device: Indwelling Catheter Procedure: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Will keep the long term team blinded as to the use of these narcotics since that might bias their decision making.
Primary Purpose: Treatment
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 : March 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 2 (IPC alone)
Patients undergo IPC placement.
Device: Indwelling Catheter
Receive IPC

Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Experimental: Group I (IPC, doxycycline)
Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Drug: Doxycycline
Receive via IPC
Other Name: Doxycycline Monohydrate

Device: Indwelling Catheter
Receive IPC

Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Time to pleural catheter removal [ Time Frame: 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 [ Time Frame: Up to 1 year ]
  2. Indwelling pleural catheters (IPC) complications [ Time Frame: Up to 1 year ]
  3. Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline up to 1 year ]
  6. Procedure-associated pain [ Time Frame: Up to 1 year ]
  7. Need for hospitalization due to pleurodesis pain [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465774


Contacts
Layout table for location contacts
Contact: David Ost, MD 713-792-6238 dost@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David Ost    713-792-6238      
Principal Investigator: David Ost         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: David Ost M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03465774     History of Changes
Other Study ID Numbers: 2017-0973
NCI-2018-00630 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0973 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Diseases
Anti-Bacterial Agents
Pleural Effusion, Malignant
Pleural Effusion
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Doxycycline
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents