Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/22/2018 |
| Start Date: | March 8, 2018 |
| End Date: | December 2020 |
| Contact: | David Ost, MD |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-792-6238 |
A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
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.
This is an investigational study. Doxycycline and IPCs are FDA approved and commercially
available for the treatment of different types of infections and pleural effusions. Either or
both can be done even if you do not take part in this study as part of your regular care. It
is consider investigational to compare the results of IPC alone and IPC plus doxycycline.
The study doctor can describe how the IPC and doxycycline are designed to work.
Up to 208 participants will take part in this study. All will be enrolled at MD Anderson.
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.
This is an investigational study. Doxycycline and IPCs are FDA approved and commercially
available for the treatment of different types of infections and pleural effusions. Either or
both can be done even if you do not take part in this study as part of your regular care. It
is consider investigational to compare the results of IPC alone and IPC plus doxycycline.
The study doctor can describe how the IPC and doxycycline are designed to work.
Up to 208 participants will take part in this study. All will be enrolled at MD Anderson.
Before the IPC is inserted, you will complete 2 questionnaires about your quality of life and
any symptoms you may have. These should take no more than 10 minutes to complete.
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.
You will have the choice to receive either an IPC alone or an IPC with doxycycline.
Regardless of what you decide, you will be followed for up to 1 year.
If you choose IPC with doxycycline, 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 related to fentanyl.
About 5 days (+/- 2 days) after the IPC has been placed, you will have a clinic visit in
which 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, you will
have a chest x-ray, 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 at home. This is part of the standard of
care, and you will be provided a container and method for measuring the amount of fluid.
Based on the results of the above Day 5 check-up, if you are found to be ineligible to
receive doxycycline, 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 doxycycline.
If you are found to be eligible to receive doxycycline, you will receive fentanyl by vein
over a few minutes, if needed to help control your pain. Your doctor will then begin to drain
your catheter and doxycycline will be placed in the catheter. The catheter will be capped for
1 hour and then drained again.
Length of Study Participation:
If you receive it, you will receive doxycycline 1 time. You will be followed for 1 year after
the catheter is removed, regardless of whether or not you receive doxycycline. Your
participation on this study will be over if you withdraw consent or the study closes,
whichever takes place first.
Follow-Up:
Between 10 and 14 days after you have the catheter placed, 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 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 your lungs.
- You will complete the same 2 questionnaires that you completed before your IPC was
placed.
One (1) time each month for up to 1 year 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. You will complete the same 2 questionnaires that you completed before your
IPC was placed. Each phone call should last about 10-15 minutes.
any symptoms you may have. These should take no more than 10 minutes to complete.
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.
You will have the choice to receive either an IPC alone or an IPC with doxycycline.
Regardless of what you decide, you will be followed for up to 1 year.
If you choose IPC with doxycycline, 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 related to fentanyl.
About 5 days (+/- 2 days) after the IPC has been placed, you will have a clinic visit in
which 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, you will
have a chest x-ray, 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 at home. This is part of the standard of
care, and you will be provided a container and method for measuring the amount of fluid.
Based on the results of the above Day 5 check-up, if you are found to be ineligible to
receive doxycycline, 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 doxycycline.
If you are found to be eligible to receive doxycycline, you will receive fentanyl by vein
over a few minutes, if needed to help control your pain. Your doctor will then begin to drain
your catheter and doxycycline will be placed in the catheter. The catheter will be capped for
1 hour and then drained again.
Length of Study Participation:
If you receive it, you will receive doxycycline 1 time. You will be followed for 1 year after
the catheter is removed, regardless of whether or not you receive doxycycline. Your
participation on this study will be over if you withdraw consent or the study closes,
whichever takes place first.
Follow-Up:
Between 10 and 14 days after you have the catheter placed, 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 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 your lungs.
- You will complete the same 2 questionnaires that you completed before your IPC was
placed.
One (1) time each month for up to 1 year 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. You will complete the same 2 questionnaires that you completed before your
IPC was placed. Each phone call should last about 10-15 minutes.
Inclusion Criteria:
1. Outpatients with MPE undergoing IPC placement
2. Age 18 or older
3. Sufficient mental capacity to provide informed consent and answer SF-6D and Borg score
questions
4. Inpatients that are expected to be discharged within 5 days of receiving an indwelling
pleural catheter
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. Pregnancy
5. Previous intrapleural therapy for MPE on the same side
6. ECOG of 4 and life expectancy
7. Doxycycline allergy
8. Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
9. Chylous effusions associated with malignant disease
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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