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



Status:Not yet recruiting
Conditions:Lung Cancer, Cancer, Cancer, Pulmonary
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2016
Contact:David Ost, MD
Phone:713-745-8775

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A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

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.

IPC Placement and Placement Follow-Up:

Before the IPC is inserted, participant will complete 2 questionnaires about their quality
of life and any symptoms they may have. It should take no more than 15-20 minutes to
complete. Participant will also have a chest x-ray and they will rate their pain on a scale
of 1-10. These tests are all part of participant's standard of care and can be explained to
them in more detail by their doctor. Participant will be required to sign a separate consent
form in order to have the IPC placed. Participant's doctor will give them detailed
instructions about the IPC placement procedure, including its risks.

After the IPC is placed, the doctor will give participant a prescription for a fentanyl
patch to help control pain. The study staff will tell participant 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, participant will have a clinic
visit where they will be checked up on as part of their standard of care. It is important
that participant wears their fentanyl patch in the morning before this visit. At this clinic
visit, the results of a previously performed chest x-ray will be reviewed, participant will
be asked to rate their pain on a scale of 1-10, and they will be asked how much fluid has
drained from their catheter.

Based on the results of the above Day 5 check-up, if participant is found to be ineligible
to receive the study drug, the fentanyl patch will be taken off and they will be followed as
part of their usual care. However, participant will still considered to be on study and they
will be followed the same as a participant who receives the study drug.

If participant is found to be eligible to receive the study drug, they will receive fentanyl
by vein over a few minutes, if needed to help control their pain. The study staff will then
begin to drain participant's 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 participant will receive doxycycline or saline, they 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 participant is in Group 1, they will receive doxycycline.

- If participant is in Group 2, they will receive saline.

Neither participant nor the study doctor will know if they are receiving doxycycline or
saline. However, if needed for participant's safety, the study staff will be able to find
out what they are receiving.

Length of Study Participation:

Participant will receive doxycycline or saline 1 time on this study. Patient's participation
on this study will be over if they withdraw consent or the study closes, whichever takes
place first.

Follow-Up:

Between 10-14 days after participant has received either doxycycline or saline, they will
come to the clinic as part of their usual standard of care so the doctor can check their 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.
Participant will continue to have this visit 1 time each month as part of their standard of
care until the catheter is removed. During each of these visits:

- Participant will have a chest x-ray to check the status of their lungs.

- Participant will complete the same 2 questionnaires that they completed before their
IPC was placed.

Long-Term Follow-Up:

One (1) time each month after the IPC is removed, participant will be called and asked how
they are doing, if they are having any side effects, if the disease has come back, and about
their overall quality of life. Some of this information may be collected from participant's
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.

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
7. Doxycycline allergy

8. Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)
We found this trial at
1
site
1515 Holcombe Blvd
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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Houston, TX
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