Trial Outcomes & Findings for Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis (NCT NCT02623959)
NCT ID: NCT02623959
Last Updated: 2019-08-07
Results Overview
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).
TERMINATED
PHASE4
3 participants
1 month
2019-08-07
Participant Flow
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.
Participant milestones
| Measure |
Indwelling Pleural Catheters (Randomized to Saline)
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.
|
Indwelling Pleural Catheters+Doxycycline (Randomized to Rx Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Indwelling Pleural Catheters (Randomized to Saline)
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.
|
Indwelling Pleural Catheters+Doxycycline (Randomized to Rx Arm
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.
|
|---|---|---|
|
Overall Study
Progression
|
0
|
1
|
Baseline Characteristics
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
Baseline characteristics by cohort
| Measure |
Indwelling Pleural Catheters (IPC) (Randomized to 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. 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
|
IPC Plus Doxycycline (Randomized to Rx Arm)
n=1 Participants
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
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Due to slow accrual and the design of the study the protocol was terminated. No data was collected and no analysis was done.
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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 1 monthPopulation: Due to slow accrual and the design of the study the protocol was terminated and no analysis was done.
Outcome measures
Outcome data not reported
Adverse Events
Indwelling Pleural Catheters (Randomized to Saline)
Indwelling Pleural Catheters Plus Doxycycline (Randomized to R
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ost,David,M.D. / [email protected]
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place