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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01670786
Other study ID # GPPOT-02
Secondary ID
Status Completed
Phase Phase 4
First received August 7, 2012
Last updated May 12, 2014
Start date January 2010
Est. completion date July 2013

Study information

Verified date May 2014
Source Grupo de Pesquisa em Pleura e Oncologia Toracica
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural effusion, with minimal adverse events, especially reducing dose.


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 ClĂ­nicas - 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
pleurodesis
Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion

Locations

Country Name City State
Brazil Hospital Aristides Maltez Salvador BA

Sponsors (3)

Lead Sponsor Collaborator
Grupo de Pesquisa em Pleura e Oncologia Toracica Instituto do Cancer do Estado de São Paulo, Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Efficacy of iodopovidone as an agent for pleurodesis The efficacy assessment was based on need of additional pleural surgical procedures. Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure No
Primary 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. Until 30th day after surgical procedure Yes
Secondary Quality of life Quality of life questionnaires were applied until 1 week before the procedure date and on thirty days postoperative as well. Until 1 week before the procedure date and 1 month after it No
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