Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Pleural Effusion

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Fentanyl

Doxycycline

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

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

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Questionnaires

Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl Patch

Fentanyl 50 mcg given by vein prior to catheter draining.

Fentanyl (IV)

Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Saline

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.

Phone Calls

David Ost, MD

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, 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.

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

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).

M.D. Anderson Cancer Center

Due to slow accrual and the design of the study the protocol was terminated and Adverse Events was not collected.

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. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.

Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After the IPC is removed, partici

Indwelling Pleural Catheters (Randomized to Saline)

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. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.

Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After th

Indwelling Pleural Catheters Plus Doxycycline (Randomized to R

Indwelling Pleural Catheters (IPC) (Randomized to Saline)

IPC Plus Doxycycline (Randomized to Rx Arm)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

2 participants withdrew before randomization

Due to slow accrual and the design of the study the protocol was terminated and no analysis or adverse event was reported.

Ost,David,M.D. / DOST@MDANDERSON.ORG

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.

Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After the IPC is removed, partici

Indwelling Pleural Catheter (IPC) + Saline

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 Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After th

Indwelling Pleural Catheter (IPC) + Doxycycline

Due to slow accrual and the design of the study the protocol was terminated. No data was collected and no analysis was done.

The Primary Outcomes of Interest Will be Time to Catheter Removal.

Due to slow accrual and the design of the study the protocol was terminated and no analysis was done.

Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality

On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, saline instilled, catheter capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale (VAS) as well, patient discharged home.

Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented.

On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, doxycycline instilled, Catheter is capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale as well, patient discharged home.

Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented.

Spots Global Cancer Trial Database for fentanyl by vein