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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Cancers; Malignant Pleural Effusions
• Intervention / Treatment: Behavioral: Questionnaires; Drug: Fentanyl Patch; Drug: Fentanyl (IV); Other: Saline; Behavioral: Phone Calls; Drug: Doxycycline

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indwelling Pleural Catheter (IPC) + Saline; 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.	Behavioral: Questionnaires; Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.; Other Names: Surveys; Drug: Fentanyl Patch; Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.; Drug: Fentanyl (IV); Fentanyl 50 mcg given by vein prior to catheter draining.; Other Names: Sublimaze; Other: Saline; Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.; Behavioral: Phone Calls; After the IPC is removed, participant is called one time each month by study staff to check on their status.
Active Comparator: Indwelling Pleural Catheter (IPC) + Doxycycline; 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	Behavioral: Questionnaires; Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.; Other Names: Surveys; Drug: Fentanyl Patch; Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.; Drug: Fentanyl (IV); Fentanyl 50 mcg given by vein prior to catheter draining.; Other Names: Sublimaze; Behavioral: Phone Calls; After the IPC is removed, participant is called one time each month by study staff to check on their status.; Drug: Doxycycline; Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.; Other Names: Vibramycin; Doryx; Periostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: David Ost, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2016
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Questionnaires; Surveys; Advanced Cancers; Doxycycline; Malignant pleural effusions; Vibramycin; Periostat; Doryx; MPE; IPC; Indwelling pleural catheter; Sublimaze; Fentanyl patch; Fentanyl by vein; :Phone calls
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Physiological Effects of Drugs; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Bacterial Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Fentanyl; Doxycycline
• Other Study ID Numbers: 2015-0142; NCI-2016-00658 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No