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

This study is currently recruiting participants.
Verified March 2013 by Grupo de Pesquisa em Pleura e Oncologia Toracica
Sponsor:
Collaborators:
Instituto do Coração (Heart Institute) do Hospital das Clínicas da FMUSP
Instituto do Cancer do Estado de São Paulo
Information provided by (Responsible Party):
Grupo de Pesquisa em Pleura e Oncologia Toracica
ClinicalTrials.gov Identifier:
NCT01670786
First received: August 7, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Pleural Effusion, Malignant
Procedure: pleurodesis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion

Further study details as provided by Grupo de Pesquisa em Pleura e Oncologia Toracica:

Primary Outcome Measures:
  • Safety of iodopovidone as an agent for pleurodesis [ Time Frame: Until 30th day after surgical procedure ] [ Designated as safety issue: Yes ]
    The safety will be 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 will be chest x-ray, eletrocardiogram and laboratory tests.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Until 1 week before the procedure date and 1 month after it ] [ Designated as safety issue: No ]
    Quality of life questionnaires will be applied until 1 week before the procedure date and on thirty days postoperative as well.


Other Outcome Measures:
  • Efficacy of iodopovidone as an agent for pleurodesis [ Time Frame: Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure ] [ Designated as safety issue: No ]
    The efficacy assessment will be based on need of additional pleural surgical procedures.


Estimated Enrollment: 52
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iodopovidone 1%
The patients enrolled in this arm will be submmitted 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 will be submmitted 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

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 will be 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 will be evaluated by the same authority pursuant and the study group will include only those who agree to participate and signed an approved. There will be included patients with malignant pleural effusion diagnosis. Main exclusion criteira will be iodine allergie, renal failure, thyroid disease, refusal to sign the informed consent and patients unable to respond the quality of life questionnaire. After inclusion, patients will be randomized and assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All procedures will be performed by infusion of the solution through a chest tube previously placed.The data analysis will involve clinical measures and complementary exams trying to evaluate all organ systems and sorting through possible adverse effects, classifying those as CTCAEV. Clinical measures will involve MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams will be chest x-ray, eletrocardiogram and laboratory tests. Such measures shall be performed in the preoperative, immediate postoperative, second, fourth, eleventh and thirty days postoperative. Quality of life questionnaires will be applied before and on thirty days postoperative as well. After that, randomized groups will be compared.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670786

Contacts
Contact: José D Andrade Neto, MD 55-71-82021142 jdnandrade@yahoo.com.br

Locations
Brazil
Hospital Aristides Maltez Recruiting
Salvador, BA, Brazil, 40285-001
Contact: José D Andrade Neto, MD    55-71-82021142    jdnandrade@yahoo.com.br   
Principal Investigator: José D Andrade Neto, MD         
Sponsors and Collaborators
Grupo de Pesquisa em Pleura e Oncologia Toracica
Instituto do Coração (Heart Institute) do Hospital das Clínicas da FMUSP
Instituto do Cancer do Estado de São Paulo
Investigators
Study Chair: Ricardo M Terra, MD, PhD InCor Heart Institute
  More Information

No publications provided

Responsible Party: Grupo de Pesquisa em Pleura e Oncologia Toracica
ClinicalTrials.gov Identifier: NCT01670786     History of Changes
Other Study ID Numbers: GPPOT-02
Study First Received: August 7, 2012
Last Updated: March 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014