Malignant Pleural EffusionPhase 2NCT01125124
Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion
A Phase 2 study testing Silver Nitrate in people with Malignant Pleural Effusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Silver Nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo General Hospital Heart Institute
São Paulo, São Paulo, 05403-000
Ricardo M Terra, MD, (55)1130696442, rmterra@uol.com.br
Ricardo M Terra, MD
About this study
Official title: Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
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.
Read the 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.
- Conditions
- Malignant Pleural Effusion
- Being tested
- Silver Nitrate
- Keywords
- Pleurodesis, Malignant pleural effusion, Silver Nitrate, Pain
- Medical subject headings
- Pleural Effusion, Malignant, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver NitrateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Silver Nitrate 1 | Active comparator | Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution. Receives: Drug: Silver Nitrate |
| Silver Nitrate 2 | Experimental | Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter. Receives: Drug: Silver Nitrate |
| Silver Nitrate 3 | Experimental | Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter. Receives: Drug: Silver Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest pain on the first five days after pleurodesis
Chest pain will be evaluated via Visual Analog Scale.
Measured: Along the first five days after treatment
Chest pain after 10 days of pleurodesis
Chest pain will be assessed using the Visual Analog Scale
Measured: On the 10th day after the procedure.
Chest pain after 30 days of pleurodesis
Chest pain will be evaluated by Visual Analog Scale
Measured: Within 30 days of the procedure
Secondary outcomes (3)
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).
Measured: After 30 days of the procedure
Dyspnea
Dyspnea will be evaluated through the British MRC dyspnea scale.
Measured: Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure.
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.
Measured: Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo M Terra, MD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125124
- Sponsor's protocol ID
- 1041/09
- Other IDs
- 1041/09
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16100154
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
- ClinicalTrials.gov ID
- NCT01125124
- Acronym / sponsor ID
- 1041/09
- Conditions
- Malignant Pleural Effusion
- Keywords
- Pleurodesis, Malignant pleural effusion, Silver Nitrate, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silver Nitrate 1 | Active comparator | Drug: Silver NitratePatients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution. |
| Silver Nitrate 2 | Experimental | Drug: Silver NitratePatients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter. |
| Silver Nitrate 3 | Experimental | Drug: Silver NitratePatients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver NitrateInstilation 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. | Drug | Silver Nitrate 1, Silver Nitrate 2, Silver Nitrate 3 |
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
3 secondary outcomes
Effectiveness of the pleurodesis
Time frame: After 30 days of the procedure
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
- Background: PubMed 16100154Paschoalini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Sao Paulo General Hospital Heart Institute
São Paulo, Brazil
Ricardo M Terra, MD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silver Nitrate in people with Malignant Pleural Effusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest pain on the first five days after pleurodesis (time frame: Along the first five days after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.