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

Pleural Effusion, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670786
• Other study ID #: GPPOT-02
• 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 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.

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

• Pleural Effusion
• Pleural Effusion, Malignant

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