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

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

Study Overview

• Status: Completed
• Conditions: Pleural Effusion, Malignant
• Intervention / Treatment: Procedure: pleurodesis

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil, 40285-001
      • Hospital Aristides Maltez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iodopovidone 1%; The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity.	Procedure: pleurodesis; Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
EXPERIMENTAL: Iodopovidone 2%; The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity.	Procedure: pleurodesis; Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Grupo de Pesquisa em Pleura e Oncologia Toracica
• Collaborators: Instituto do Cancer do Estado de São Paulo; Instituto do Coracao
• Investigators: Study Chair: Ricardo M Terra, MD, PhD, InCor Heart Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (ESTIMATE): August 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: GPPOT-02