Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion

NCT ID: NCT01670786

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

Conditions

Pleural Effusion, Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Iodopovidone 1%

The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity.

Group Type: EXPERIMENTAL

pleurodesis

Intervention Type: PROCEDURE

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

Iodopovidone 2%

The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity.

Group Type: EXPERIMENTAL

pleurodesis

Intervention Type: PROCEDURE

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

Interventions

pleurodesis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: collaborator

Grupo de Pesquisa em Pleura e Oncologia Toracica

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo M Terra, MD, PhD

Role: STUDY_CHAIR

InCor Heart Institute

Locations

Hospital Aristides Maltez

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

GPPOT-02

Identifier Type: -

Identifier Source: org_study_id