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

Primary Purpose

Malignant Pleural Effusion

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Silver Nitrate
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Pleurodesis, Malignant pleural effusion, Silver Nitrate, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo General Hospital Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Silver Nitrate 1

Silver Nitrate 2

Silver Nitrate 3

Arm Description

Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.

Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.

Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.

Outcomes

Primary Outcome Measures

Chest pain on the first five days after pleurodesis
Chest pain will be evaluated via Visual Analog Scale.
Chest pain after 10 days of pleurodesis
Chest pain will be assessed using the Visual Analog Scale
Chest pain after 30 days of pleurodesis
Chest pain will be evaluated by Visual Analog Scale

Secondary Outcome Measures

Effectiveness of the pleurodesis
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
Dyspnea will be evaluated through the British MRC dyspnea scale.
Adverse effects
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.

Full Information

First Posted
April 26, 2010
Last Updated
May 14, 2010
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01125124
Brief Title
Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion
Official Title
Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
Keywords
Pleurodesis, Malignant pleural effusion, Silver Nitrate, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silver Nitrate 1
Arm Type
Active Comparator
Arm Description
Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.
Arm Title
Silver Nitrate 2
Arm Type
Experimental
Arm Description
Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.
Arm Title
Silver Nitrate 3
Arm Type
Experimental
Arm Description
Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.
Intervention Type
Drug
Intervention Name(s)
Silver Nitrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chest pain on the first five days after pleurodesis
Description
Chest pain will be evaluated via Visual Analog Scale.
Time Frame
Along the first five days after treatment
Title
Chest pain after 10 days of pleurodesis
Description
Chest pain will be assessed using the Visual Analog Scale
Time Frame
On the 10th day after the procedure.
Title
Chest pain after 30 days of pleurodesis
Description
Chest pain will be evaluated by Visual Analog Scale
Time Frame
Within 30 days of the procedure
Secondary Outcome Measure Information:
Title
Effectiveness of the pleurodesis
Description
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).
Time Frame
After 30 days of the procedure
Title
Dyspnea
Description
Dyspnea will be evaluated through the British MRC dyspnea scale.
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.
Title
Adverse effects
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo M Terra, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital Heart Institute
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo M Terra, MD
Phone
(55)1130696442
Email
rmterra@uol.com.br
First Name & Middle Initial & Last Name & Degree
Ricardo M Terra, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16100154
Citation
Paschoalini Mda S, Vargas FS, Marchi E, Pereira JR, Jatene FB, Antonangelo L, Light RW. Prospective randomized trial of silver nitrate vs talc slurry in pleurodesis for symptomatic malignant pleural effusions. Chest. 2005 Aug;128(2):684-9. doi: 10.1378/chest.128.2.684.
Results Reference
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Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

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