Intrapleural Catheter Daily Versus Three Times a Week Drainage - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00761618

Purpose

The investigators primary objective is to show that draining the intrapleural catheter (IPC) every day (study arm ED) rather than 3 days a week (study arm TDW) will not result in fewer patients with pleurodesis (Pd).

Condition	Intervention	Phase
Advanced Cancer Pleural Effusion	Procedure: Intrapleural catheter (IPC) drained Procedure: IPC Placement Radiation: Chest X-Ray	Phase III

MedlinePlus related topics: Cancer X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if draining the IPC every day is better than draining it 3 times a week [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	310
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IPC drained every day	Procedure: Intrapleural catheter (IPC) drained IPC drained daily (Group 1) or 3 times per week (Group 2) Procedure: IPC Placement IPC placed in chest cavity to drain excess fluid Radiation: Chest X-Ray Chest X-Rays at 3 and 6 month follow up visits
2: Experimental IPC drained 3 times a week	Procedure: Intrapleural catheter (IPC) drained IPC drained daily (Group 1) or 3 times per week (Group 2) Procedure: IPC Placement IPC placed in chest cavity to drain excess fluid Radiation: Chest X-Ray Chest X-Rays at 3 and 6 month follow up visits

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Detailed Description:

An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At M. D. Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.

Before IPC Placement:

Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:

You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. Both questionnaires will take about 20-30 minutes to complete.

IPC placement:

You will have an IPC placed to drain the fluid in your chest cavity. You will be given a separate consent for to sign for this procedure and your doctor will give you detailed instructions regarding the procedure itself.

Study Groups:

A chest x-ray will be performed right after the IPC placement. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the following day when you return to clinic for follow up. Group 1 will have their IPC drained every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when and how to drain your catheter.

Follow-Up Visits:

Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit so the doctor can check your IPC for possible leaking, infection, and see how much pleural fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic every 4 weeks until your IPC is removed. During each follow-up visit the following tests and procedures will be performed to see how your condition has changed:

You will have a chest x-ray to see if the amount of pleural fluid has decreased and to see if your lung has re-expanded.
You will perform the 6 minute walk test.
You will complete the same 2 questionnaires.
The IPC will be drained.

After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D. Anderson or at your local doctor's office. At these visits you will have chest x-rays to see if the pleural fluid has come back or not.

The study personnel will contact you by phone, email or mail periodically during the study and at 3 months and 6 months after the IPC has been removed to check on your status. The phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be asked how you are doing and if you have any questions or concerns that you may want to discuss with the your doctor. You will also be asked if you have had a chest x-ray since being off study. If you have had an x-ray, you will be asked to share the results with the study doctor.

This is an investigational study. Up to 310 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patients with symptomatic pleural effusion requiring placement of an IPC.
Signed informed consent prior to any study related procedures.
Subject must be age 18 years or over.

Exclusion:

Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
Evidence of empyema or history of empyema of the affected hemithorax
Non-correctable bleeding diathesis
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Participation in any clinical trial that prevents randomization of the subject to either strategy.
Clinical evidence of skin infection at the potential site of IPC placement.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761618

Contacts

Contact: Carlos A. Jimenez, MD	713-563-4252
Contact: Dana Bethancourt, CCRC, RN

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Linda Foot 713-563-8841
Principal Investigator: Carlos A. Jimenez, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Carlos A. Jimenez, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Carlos A. Jimenez, MD/Associate Professor )
Study ID Numbers:	2007-0808
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761618
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

intrapleural catheter
IPC
pleurodesis
Pd

pleural effusion
Recurrent malignant pleural effusion
MPE
pleural inflammatory response

Study placed in the following topic categories:

Pleural Effusion
Respiratory Tract Diseases
Pleural Diseases
Pleural Effusion, Malignant
Recurrence

ClinicalTrials.gov processed this record on February 11, 2009