Clinical Trial: Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.

Brief Summary: The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

Detailed Summary:

Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents.

Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome:

• Chest pain on the first five days after pleurodesis [ Time Frame: Along the first five days after treatment ]
  Chest pain will be evaluated via Visual Analog Scale.
• Chest pain after 10 days of pleurodesis [ Time Frame: On the 10th day after the procedure. ]
  Chest pain will be assessed using the Visual Analog Scale
• Chest pain after 30 days of pleurodesis [ Time Frame: Within 30 days of the procedure ]
  Chest pain will be evaluated by Visual Analog Scale

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Effectiveness of the pleurodesis [ Time Frame: After 30 days of the procedure ]
  On hospital discharge, five days after the procedure, patients are submitted to chest computerized tomography (CT). After 30 days of the procedure, patients are submitted to another chest CT and the volume of pleural effusion is calculated and compared to that of the hospital discharge date (calculated by the 5th day CT).
• Dyspnea [ Time Frame: Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure. ]
  Dyspnea will be evaluated through the British MRC dyspnea scale.
• Adverse effects [ Time Frame: Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure ]
  The safety of the treatment will be assessed both by monitoring of complete blood counts, renal function, liver function and inflammation markers, as well as monitoring of body temperature, arterial blood pressure and heart rate. The occurrence of adverse side effects will be assessed using the United States National Cancer Institute Common Terminology Criteria for Adverse Events v.3.0.

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: April 26, 2010
Date Started: August 2009
Date Completion: December 2010
Last Updated: May 14, 2010
Last Verified: April 2010