Pleural Effusion, MalignantPhase 4NCT01670786
Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
A Phase 4 study testing pleurodesis in people with Pleural Effusion, Malignant, run by Grupo de Pesquisa em Pleura e Oncologia Toracica at 1 site in Brazil.
Trial summary
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural effusion, with minimal adverse events, especially reducing dose. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jul 2013
- Phase
- Phase 4
- 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
- Recurrent pleural effusion
- Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
- Karnofsky index > 40.
- Agreed to participate in the study and sign an Informed Consent
Who cannot join
- Thrombocytopenia or coagulation disorders
- Patients with impaired renal function
- Pleural or active systemic infection
- Massive neoplastic infiltration of the skin
- Inability to understand the quality of life questionnaire
- Previous pleural procedures
- Allergy to iodine
- Thyroid disorders
Trial locations and contacts
1 site in 1 country.
About this study
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural effusion, with minimal adverse events, especially reducing dose.
Read the detailed description
Background: Chemical pleurodesis is the treatment of choice in most cases of malignant pleural effusion. The literature mentions a variety of chemicals which may be used for this purpose, each with its own advantages and disadvantages. The iodopovidone has been recently studied due to the existence of some side effects of other agents. Nevertheless, there are still some questions in the literature regarding its safety and possible adverse effects. Because of these questions, we propose the development of a study to ensure the safety and efficacy of iodopovidone as a pleurodesis sclerosing agent.
Objective: The main purpose of this study is to evaluate the safety of pleurodesis for malignant pleural effusion using iodopovidone as a sclerosing agent in different doses. The secondary objectives are to determine clinical efficacy and quality of life of the patients after realization of the proposed procedure.
Methods: There will be a randomized clinical trial, covering patients diagnosed with malignant pleural effusion at Hospital Aristides Maltez - Bahia League Against Cancer. The research was revised and approved by the Ethics in Research of the Heart Institute, Hospital das Clínicas - FMUSP and of the Hospital Aristides Maltez - Bahia League Against Cancer. The free and informed consent was evaluated by the same authority pursuant and the study group included only those who agree to participate and signed an approved. There included patients with malignant pleural effusion diagnosis. Main exclusion criteria were iodine allergia, renal failure, thyroid disease, refusal to sign the informed consent and patients unable to respond the quality of life questionnaire. After inclusion, patients were randomized and assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All procedures were performed by infusion of the solution through a chest tube previously placed.The data analysis involved clinical measures and complementary exams trying to evaluate all organ systems and sorting through possible adverse effects, classifying those as CTCAEV. Clinical measures involved MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests. Such measures were performed in the preoperative, immediate postoperative, second, fourth, eleventh and thirty days postoperative. Quality of life questionnaires was applied before and on thirty days postoperative as well. After that, randomized groups were compared.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- pleurodesis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleurodesisProcedure or surgery
Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
| Study group | Role | What they receive |
|---|---|---|
| Iodopovidone 1% | Experimental | The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity. Receives: Procedure: pleurodesis |
| Iodopovidone 2% | Experimental | The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity. Receives: Procedure: pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of iodopovidone as an agent for pleurodesis
The safety was assessed by mean clinical measures as MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.
Measured: Until 30th day after surgical procedure
Secondary outcomes (1)
Quality of life
Quality of life questionnaires were applied until 1 week before the procedure date and on thirty days postoperative as well.
Measured: Until 1 week before the procedure date and 1 month after it
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Pesquisa em Pleura e Oncologia Toracica
- Sponsor type
- Research network
- Collaborators
- Instituto do Coracao, Instituto do Cancer do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Ricardo M Terra, MD, PhD, Study chair, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670786
- Sponsor's protocol ID
- GPPOT-02
- Status last verified
- May 2014
- First submitted
- 7 Aug 2012
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT01670786
- Acronym / sponsor ID
- GPPOT-02
- Conditions
- Pleural Effusion, Malignant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Grupo de Pesquisa em Pleura e Oncologia ToracicaResearch network
- Collaborators
- Instituto do Coracao, Instituto do Cancer do Estado de São Paulo
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Aug 2012 (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.
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural effusion, with minimal adverse events, especially reducing dose.
Detailed description
Background: Chemical pleurodesis is the treatment of choice in most cases of malignant pleural effusion. The literature mentions a variety of chemicals which may be used for this purpose, each with its own advantages and disadvantages. The iodopovidone has been recently studied due to the existence of some side effects of other agents. Nevertheless, there are still some questions in the literature regarding its safety and possible adverse effects. Because of these questions, we propose the development of a study to ensure the safety and efficacy of iodopovidone as a pleurodesis sclerosing agent.
Objective: The main purpose of this study is to evaluate the safety of pleurodesis for malignant pleural effusion using iodopovidone as a sclerosing agent in different doses. The secondary objectives are to determine clinical efficacy and quality of life of the patients after realization of the proposed procedure.
Methods: There will be a randomized clinical trial, covering patients diagnosed with malignant pleural effusion at Hospital Aristides Maltez - Bahia League Against Cancer. The research was revised and approved by the Ethics in Research of the Heart Institute, Hospital das Clínicas - FMUSP and of the Hospital Aristides Maltez - Bahia League Against Cancer. The free and informed consent was evaluated by the same authority pursuant and the study group included only those who agree to participate and signed an approved. There included patients with malignant pleural effusion diagnosis. Main exclusion criteria were iodine allergia, renal failure, thyroid disease, refusal to sign the informed consent and patients unable to respond the quality of life questionnaire. After inclusion, patients were randomized and assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All procedures were performed by infusion of the solution through a chest tube previously placed.The data analysis involved clinical measures and complementary exams trying to evaluate all organ systems and sorting through possible adverse effects, classifying those as CTCAEV. Clinical measures involved MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests. Such measures were performed in the preoperative, immediate postoperative, second, fourth, eleventh and thirty days postoperative. Quality of life questionnaires was applied before and on thirty days postoperative as well. After that, randomized groups were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodopovidone 1% | Experimental | Procedure: pleurodesisThe patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity. |
| Iodopovidone 2% | Experimental | Procedure: pleurodesisThe patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity. |
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
- Recurrent pleural effusion
- Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
- Karnofsky index > 40.
- Agreed to participate in the study and sign an Informed Consent
Key exclusion criteria (8 listed)
- Thrombocytopenia or coagulation disorders
- Patients with impaired renal function
- Pleural or active systemic infection
- Massive neoplastic infiltration of the skin
- Inability to understand the quality of life questionnaire
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 |
|---|---|---|
| pleurodesisComparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion | Procedure or surgery | Iodopovidone 1%, Iodopovidone 2% |
Primary outcome
Safety of iodopovidone as an agent for pleurodesis
Time frame: Until 30th day after surgical procedure
The safety was assessed by mean clinical measures as MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.
1 secondary outcome
Quality of life
Time frame: Until 1 week before the procedure date and 1 month after it
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Ricardo M Terra, MD, PhD study chair
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pleurodesis in people with Pleural Effusion, Malignant, run by Grupo de Pesquisa em Pleura e Oncologia Toracica 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 8 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: finished, as of the sponsor's last update on 13 May 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of iodopovidone as an agent for pleurodesis (time frame: Until 30th day after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2014.