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Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline

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ClinicalTrials.gov Identifier: NCT03465774
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.

This is an investigational study. Doxycycline and IPCs are FDA approved and commercially available for the treatment of different types of infections and pleural effusions. Either or both can be done even if you do not take part in this study as part of your regular care. It is consider investigational to compare the results of IPC alone and IPC plus doxycycline.

The study doctor can describe how the IPC and doxycycline are designed to work.

Up to 208 participants will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Respiratory and Intrathoracic Organs Behavioral: Surveys Drug: Fentanyl Drug: Doxycycline Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Indwelling Pleural Catheter (IPC)
Participants complete 2 questionnaires before the IPC is inserted, 10 and 14 days after the catheter is placed, and 1 time each month for up to 1 year after the IPC is removed.
Behavioral: Surveys
Participants complete 2 questionnaires before the IPC is inserted, 10 and 14 days after the catheter is placed, and 1 time each month for up to 1 year after the IPC is removed.

Experimental: Indwelling Pleural Catheter (IPC) + Doxycycline

Participants complete 2 questionnaires before the IPC is inserted, 10 and 14 days after the catheter is placed, and 1 time each month for up to 1 year after the IPC is removed.

Participants given a prescription for a fentanyl patch to help control pain after the IPC is placed.

At Day 5 check up after IPC placed, participants receive Fentanyl by vein over a few minutes, if needed to help control pain. Doxycycline placed in the IPC as catheter is drained.

Behavioral: Surveys
Participants complete 2 questionnaires before the IPC is inserted, 10 and 14 days after the catheter is placed, and 1 time each month for up to 1 year after the IPC is removed.

Drug: Fentanyl

Fentanyl 12 mcg/hr patch to help control pain after the IPC is placed.

At Day 5 check up after IPC placed, participants receive Fentanyl 50 mcg by vein over a few minutes, if needed to help control pain.

Other Name: Sublimaze

Drug: Doxycycline
Doxycycline 500 mg placed in the IPC with one hour dwell time.
Other Names:
  • Vibramycin
  • Periostat
  • Doryx




Primary Outcome Measures :
  1. Time to Indwelling Pleural Catheter (IPC) Removal [ Time Frame: After IPC placement up to 1 year ]

Secondary Outcome Measures :
  1. Fluid Recurrence after Indwelling Pleural Catheter (IPC) Removal [ Time Frame: 1 time each month until IPC removed up to 1 year ]
  2. Symptom Burden Determined by Patient Self Assessment Form [ Time Frame: 10 and 14 days after the catheter is placed, and 1 time each month for up to 1 year after the IPC is removed. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients with MPE undergoing IPC placement
  2. Age 18 or older
  3. Sufficient mental capacity to provide informed consent and answer SF-6D and Borg score questions
  4. Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter

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. Pregnancy
  5. Previous intrapleural therapy for MPE on the same side
  6. ECOG of 4 and life expectancy </= 2 weeks
  7. Doxycycline allergy
  8. Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
  9. Chylous effusions associated with malignant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465774


Contacts
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Contact: David Ost, MD 713-792-6238 CR_Study_Registration@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: David Ost, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03465774     History of Changes
Other Study ID Numbers: 2017-0973
NCI-2018-00630 ( Registry Identifier: NCI CTRP )
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by M.D. Anderson Cancer Center:
Pleural effusions
Malignant neoplasms of respiratory and intrathoracic organs
Indwelling Pleural Catheter
IPC
Fentanyl
Sublimaze
Doxycycline
Vibramycin
Periostat
Doryx
Questionnaires
Surveys

Additional relevant MeSH terms:
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Pleural Effusion
Neoplasms
Pleural Diseases
Respiratory Tract Diseases
Fentanyl
Doxycycline
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents