MedTrace Logo

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

NCT02623959 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-07

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

BEHAVIORAL

Questionnaires

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

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

Saline

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

DRUG

Doxycycline

Catheter is drained then Doxycycline 500 mg 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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Ost, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-27
Primary Completion
2017-05-23
Completion
2017-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623959 on ClinicalTrials.gov