Pleural NeoplasmNCT03465774
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
An observational study of Pleural Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Neoplasm
- What is being tested?
- Doxycycline, Indwelling Catheter and Quality-of-Life Assessment
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with MPE undergoing IPC placement
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Doxycycline allergy
- Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
- Chylous effusions associated with malignant disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
David Ost, 713-792-6238
David Ost
About this study
Official title: A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Pleural Neoplasm
- Being tested
- Doxycycline, Indwelling Catheter, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Pleural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxycycline Monohydrate
Receive via IPC
Indwelling CatheterDevice
Receive IPC
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group 2 (IPC alone) | Patients undergo IPC placement. Receives: 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. Receives: Drug: Doxycycline; Device: Indwelling Catheter; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (7)
Recurrence of effusion requiring drainage after IPC
Measured: Up to 1 year
Indwelling pleural catheters (IPC) complications
Measured: Up to 1 year
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.
Measured: 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.
Measured: Baseline up to 1 year
Assessment of symptom burden
Measured: Baseline up to 1 year
Procedure-associated pain
Measured: Up to 1 year
Need for hospitalization due to pleurodesis pain
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start8 Mar 2018
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Ost, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465774
- Sponsor's protocol ID
- 2017-0973
- Other IDs
- NCI-2018-00630, 2017-0973
- Status last verified
- Sep 2026
- First submitted
- 8 Mar 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT03465774
- Acronym / sponsor ID
- 2017-0973
- Conditions
- Pleural Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 (IPC alone) | – | Device: Indwelling Catheter, Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients undergo IPC placement. |
| Group I (IPC, doxycycline) | – | Drug: Doxycycline, Device: Indwelling Catheter, Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients undergo IPC placement and receive doxycycline via IPC 5 days later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with MPE undergoing IPC placement
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Doxycycline MonohydrateReceive via IPC | Drug | Group I (IPC, doxycycline) |
| Indwelling CatheterReceive IPC | Device | Group 2 (IPC alone), Group I (IPC, doxycycline) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Group 2 (IPC alone), Group I (IPC, doxycycline) |
| Questionnaire AdministrationAncillary studies | Other | Group 2 (IPC alone), Group I (IPC, doxycycline) |
| Survey AdministrationAncillary studies | Other | Group 2 (IPC alone), Group I (IPC, doxycycline) |
Primary outcome
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.
7 secondary outcomes
Recurrence of effusion requiring drainage after IPC
Time frame: Up to 1 year
Indwelling pleural catheters (IPC) complications
Time frame: Up to 1 year
Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D)
Time frame: Baseline up to 1 year
Change in dyspnea using Borg score
Time frame: Baseline up to 1 year
Assessment of symptom burden
Time frame: Baseline up to 1 year
Procedure-associated pain
Time frame: Up to 1 year
Need for hospitalization due to pleurodesis pain
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Ost principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Ost (713-792-6238, dost@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to pleural catheter removal (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.