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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01125124
First received: April 26, 2010
Last updated: May 14, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Malignant Pleural Effusion
Drug: Silver Nitrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Chest pain on the first five days after pleurodesis [ Time Frame: Along the first five days after treatment ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Chest pain will be evaluated by Visual Analog Scale


Secondary Outcome Measures:
  • Effectiveness of the pleurodesis [ Time Frame: After 30 days of the procedure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Silver Nitrate 1
Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.
Drug: Silver Nitrate
Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.
Experimental: Silver Nitrate 2
Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.
Drug: Silver Nitrate
Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.
Experimental: Silver Nitrate 3
Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.
Drug: Silver Nitrate
Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy.
  • Recurrent and symptomatic malignant pleural effusion.
  • Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.
  • Karnofsky Performance Status >30
  • Agreement to participate of the study by signing of the Informed Consent Term.

Exclusion Criteria:

  • Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).
  • Active pleural or systemic infection.
  • Massive skin neoplastic infiltration.
  • Inability of understanding the pain scale.
  • Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).
  • Refusal to participate of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125124

Locations
Brazil
University of Sao Paulo General Hospital Heart Institute Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Ricardo M Terra, MD    (55)1130696442    rmterra@uol.com.br   
Principal Investigator: Ricardo M Terra, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Ricardo M Terra, MD University of Sao Paulo General Hospital
  More Information

Publications:
Responsible Party: Dr Ricardo Mingarini Terra, INCOR-HCFMUSP
ClinicalTrials.gov Identifier: NCT01125124     History of Changes
Other Study ID Numbers: 1041/09, 1041/09
Study First Received: April 26, 2010
Last Updated: May 14, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:
Pleurodesis
Malignant pleural effusion
Silver Nitrate
Pain

Additional relevant MeSH terms:
Pleural Diseases
Pleural Effusion
Pleural Effusion, Malignant
Neoplasms
Neoplasms by Site
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Silver Nitrate
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014