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Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis

Primary Purpose

Advanced Cancers, Malignant Pleural Effusions

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Fentanyl Patch
Fentanyl (IV)
Saline
Doxycycline
Phone Calls
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancers focused on measuring Advanced Cancers, Malignant pleural effusions, MPE, Indwelling pleural catheter, IPC, Questionnaires, Surveys, Fentanyl patch, Fentanyl by vein, Sublimaze, Doxycycline, Vibramycin, Periostat, Doryx, :Phone calls

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Outpatients with MPE undergoing IPC placement
  2. Age 18 or older
  3. Sufficient mental capacity to answer SF-6D and Borg score questions.

Exclusion Criteria:

  1. Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
  2. Inability or unwillingness to give informed consent
  3. Inability to perform phone call and clinical follow-up at MDACC
  4. Previous intrapleural therapy for MPE on the same side
  5. Chylous effusions associated with malignant disease
  6. ECOG of 4 and life expectancy </= 2 weeks
  7. Doxycycline allergy
  8. Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indwelling Pleural Catheter (IPC) + Saline

Indwelling Pleural Catheter (IPC) + Doxycycline

Arm Description

Symptom 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.

Symptom 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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 4, 2015
Last Updated
July 26, 2019
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02623959
Brief Title
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
Official Title
A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
IPC Placement and Placement Follow-Up: Before the IPC is inserted, you will complete 2 questionnaires about your quality of life and any symptoms you may have. It should take no more than 15-20 minutes to complete. You will also have a chest x-ray and you will rate your pain on a scale of 1-10. These tests are all part of your standard of care and can be explained to you in more detail by your doctor. You will be required to sign a separate consent form in order to have the IPC placed. Your doctor will give you detailed instructions about the IPC placement procedure, including its risks. After the IPC is placed, the doctor will give you a prescription for a fentanyl patch to help control pain. The study staff will tell you how and when to wear the fentanyl patch and about any side effects that are associated with fentanyl. About 5 days (+/- 2 days) after the IPC has been placed, you will have a clinic visit where you will be checked up on as part of your standard of care. It is important that you wear your fentanyl patch in the morning before this visit. At this clinic visit, the results of a previously performed chest x-ray will be reviewed, you will be asked to rate your pain on a scale of 1-10, and you will be asked how much fluid has drained from your catheter. Based on the results of the above Day 5 check-up, if you are found to be ineligible to receive the study drug, the fentanyl patch will be taken off and you will be followed as part of your usual care. However, you will still considered to be on study and you will be followed the same as a participant who receives the study drug. If you are found to be eligible to receive the study drug, you will receive fentanyl by vein over a few minutes, if needed to help control your pain. The study staff will then begin to drain your catheter and either doxycycline or saline (described below) will be placed in the catheter. The catheter will be capped for 1 hour and then drained again. To determine if you will receive doxycycline or saline, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. If you are in Group 1, you will receive doxycycline. If you are in Group 2, you will receive saline. Neither you nor the study doctor will know if you are receiving doxycycline or saline. However, if needed for your safety, the study staff will be able to find out what you are receiving. Length of Study Participation: You will receive doxycycline or saline 1 time on this study. Your participation on this study will be over if you withdraw consent or the study closes, whichever takes place first. Follow-Up: Between 10-14 days after you have received either doxycycline or saline, you will come to the clinic as part of your usual standard of care so the doctor can check your IPC for possible leaking, infection, to see how much fluid has drained, and to remove any sutures. The catheter may be removed if you have it is leaking or shows signs of infection. You will continue to have this visit 1 time each month as part of your standard of care until the catheter is removed. During each of these visits: You will have a chest x-ray to check the status of your lungs. You will complete the same 2 questionnaires that you completed before your IPC was placed. Long-Term Follow-Up: One (1) time each month after the IPC is removed, you will be called and asked how you are doing, if you are having any side effects, if the disease has come back, and about your overall quality of life. Some of this information may be collected from your medical record. Each phone call should last about 5-10 minutes. This is an investigational study. Doxycycline is FDA approved and commercially available for the treatment of different types of infections and pleural effusions. It is considered investigational to compare doxycycline to saline to treat pleural effusions. Up to 250 participants will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancers, Malignant Pleural Effusions
Keywords
Advanced Cancers, Malignant pleural effusions, MPE, Indwelling pleural catheter, IPC, Questionnaires, Surveys, Fentanyl patch, Fentanyl by vein, Sublimaze, Doxycycline, Vibramycin, Periostat, Doryx, :Phone calls

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indwelling Pleural Catheter (IPC) + Saline
Arm Type
Experimental
Arm Description
Symptom 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.
Arm Title
Indwelling Pleural Catheter (IPC) + Doxycycline
Arm Type
Active Comparator
Arm Description
Symptom 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
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.
Intervention Type
Drug
Intervention Name(s)
Fentanyl Patch
Intervention Description
Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.
Intervention Type
Drug
Intervention Name(s)
Fentanyl (IV)
Other Intervention Name(s)
Sublimaze
Intervention Description
Fentanyl 50 mcg given by vein prior to catheter draining.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Vibramycin, Periostat, Doryx
Intervention Description
Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.
Intervention Type
Behavioral
Intervention Name(s)
Phone Calls
Intervention Description
After the IPC is removed, participant is called one time each month by study staff to check on their status.
Primary Outcome Measure Information:
Title
The Primary Outcomes of Interest Will be Time to Catheter Removal.
Description
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).
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality
Time Frame
baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients with MPE undergoing IPC placement Age 18 or older Sufficient mental capacity to answer SF-6D and Borg score questions. 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ost, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis

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