Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623959
Recruitment Status : Terminated (Slow Accrual)
First Posted : December 8, 2015
Results First Posted : July 26, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Advanced Cancers
Malignant Pleural Effusions
Interventions Behavioral: Questionnaires
Drug: Fentanyl Patch
Drug: Fentanyl (IV)
Other: Saline
Drug: Doxycycline
Behavioral: Phone Calls
Enrollment 3
Recruitment Details Outpatients with MPE eligible for IPC,no evidence of extensive loculation or hydropneumothorax or other contraindication to pleurodesis or narcotics;aged 18 or older;and has sufficient mental capacity to answer SF-6D and Borg score questions. Out of 3 participants 2 withdrew before randomization.
Pre-assignment Details  
Arm/Group Title Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters+Doxycycline (Randomized to Rx Arm
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 0 1
Completed 0 0 [1]
Not Completed 0 1
Reason Not Completed
Progression             0             1
[1]
due to progression
Arm/Group Title Indwelling Pleural Catheters (IPC) (Randomized to Saline) IPC Plus Doxycycline (Randomized to Rx Arm) Total
Hide Arm/Group 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. 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

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

Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
2 participants withdrew before randomization
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0
0
   0.0%
0
   0.0%
Between 18 and 65 years 0
1
 100.0%
1
 100.0%
>=65 years 0
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 0
0
   0.0%
0
   0.0%
Male 0
1
 100.0%
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
American Indian or Alaska Native 0
0
   0.0%
0
   0.0%
Asian 0
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander 0
0
   0.0%
0
   0.0%
Black or African American 0
0
   0.0%
0
   0.0%
White 0
1
 100.0%
1
 100.0%
More than one race 0
0
   0.0%
0
   0.0%
Unknown or Not Reported 0
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
0
1
 100.0%
1
 100.0%
1.Primary Outcome
Title The Primary Outcomes of Interest Will be Time to Catheter Removal.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow accrual and the design of the study the protocol was terminated. No data was collected and no analysis was done.
Arm/Group Title Indwelling Pleural Catheter (IPC) + Saline Indwelling Pleural Catheter (IPC) + Doxycycline
Hide Arm/Group 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.

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Other Pre-specified Outcome
Title Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality
Hide Description [Not Specified]
Time Frame baseline and 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow accrual and the design of the study the protocol was terminated and no analysis was done.
Arm/Group Title Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Hide Arm/Group 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. 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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Due to slow accrual and the design of the study the protocol was terminated and Adverse Events was not collected.
 
Arm/Group Title Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Hide Arm/Group 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. 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

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

All-Cause Mortality
Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Indwelling Pleural Catheters (Randomized to Saline) Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Due to slow accrual and the design of the study the protocol was terminated and no analysis or adverse event was reported.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ost,David,M.D. / DOST@MDANDERSON.ORG
Organization: UT MD Anderson Cancer Center
Phone: 713-745-8775
EMail: DOst@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02623959     History of Changes
Other Study ID Numbers: 2015-0142
NCI-2016-00658 ( Registry Identifier: NCI CTRP )
First Submitted: December 4, 2015
First Posted: December 8, 2015
Results First Submitted: April 16, 2019
Results First Posted: July 26, 2019
Last Update Posted: August 7, 2019