Study Stopped
Slow Accrual
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
2 other identifiers
interventional
3
1 country
1
Brief Summary
The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in combination with saline (the current standard of care) versus IPC in combination with doxycycline as treatment for pleural effusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedStudy Start
First participant enrolled
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2017
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedAugust 7, 2019
July 1, 2019
1.1 years
December 4, 2015
April 16, 2019
July 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Outcomes of Interest Will be Time to 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, and refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication).
1 month
Other Outcomes (1)
Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality
baseline and 1 month
Study Arms (2)
Indwelling Pleural Catheter (IPC) + Saline
EXPERIMENTALSymptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status.
Indwelling Pleural Catheter (IPC) + Doxycycline
ACTIVE COMPARATORSymptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status
Interventions
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.
Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.
Fentanyl 50 mcg given by vein prior to catheter draining.
Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.
Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
Eligibility Criteria
You may qualify if:
- Outpatients with MPE undergoing IPC placement
- Age 18 or older
- Sufficient mental capacity to answer SF-6D and Borg score questions.
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 MDACC
- Previous intrapleural therapy for MPE on the same side
- Chylous effusions associated with malignant disease
- ECOG of 4 and life expectancy \</= 2 weeks
- Doxycycline allergy
- Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to slow accrual and the design of the study the protocol was terminated and no analysis or adverse event was reported.
Results Point of Contact
- Title
- Ost,David,M.D. / DOST@MDANDERSON.ORG
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David Ost, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 8, 2015
Study Start
April 27, 2016
Primary Completion
May 23, 2017
Study Completion
May 23, 2017
Last Updated
August 7, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-07