Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

January 21, 2020 updated by: Apichat Tantraworasin, Chiang Mai University

Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion: a Randomized Controlled Trial Study

This is prospective randomized control trial study. The aim of this study is to evaluate the efficacy of Iodopovidone solution for pleurodesis in palliative malignant pleural effusion (MPE) patients comparing to Talc. All adult patients who diagnosed MPE by cytology regardless primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this study. The inform and consent will be applied in all patients before treatment. Patients will be randomized to two groups; Iodopovidone group (intervention group) and Talc group (control group)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale: Malignant pleural effusion (MPE) defined as presenting malignant cell in pleural effusion. It is usually found in advanced stage cancer or cancer of pleura. Most common primary tumor causing MPE is lung cancer (37%) followed with breast cancer (16%). From previous studies, when MPE was diagnosed, the median survival was only 3-12 months depending on primary tumor. In lung cancer, median survival for stage IV with MPE was only 4 months. However, quality of life of patient is also important. These patients should have less suffer from MPE. In recent era, chemotherapy, targeted therapy and immunotherapy are very useful for advanced stage cancer patients. They can prolong survival in such patients. Therefore, pleurodesis had role for palliative treatment hoping these patient have better quality of life. Talc (composed of oxygen, silicate, magnesium and carbon) has been used as one of common substances for chemical pleurodesis since 1935 by Norman Bethune with high efficacy (90%). However, it can cause a serious complication such as acute respiratory distress syndrome (ARDS). Although an incidence of ARDS is not too high, it can make patients died, therefore, other substances have been studied instead of using Talc. Iodopovidone has been one of interesting substances used as pleurodesis substance since 2006. It is low cost, and available. One meta-analysis of 13 observational studies with 499 patients found that iodopovidone was safe with success rate of pleurodesis was 70-100%. The most common side effect was chest pain. Previously, only two randomized control trial studies reported the efficacy of iodopovidone solution comparing to Talc for pleurodesis. They found that there were no statistical significant difference either efficacy or safety between two substances. The limitation of those studies is small sample size, therefore, we would like to compare the efficacy of iodopovidone solution for chemical pleurodesis with Talc.

Objectives: To compare the efficacy of Iodopovidone solution with Talc for pleurodesis in MPE Research methodology: This is a prospective randomized control trial. All adult patients who diagnosed MPE by cytology regardless primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this study. Patients will be randomized to two groups; Iodopovidone group (intervention group) and Talc group (control group). The efficacy of both groups will be compared.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chaing Mai
      • Chiang Mai, Chaing Mai, Thailand, 50200
        • Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All MPE proved by cytology
  2. After pleural effusion was released by chest tube drainage, lung was fully expanded

Exclusion Criteria:

  1. Patients who have Karnofsky performance state ≤ 40
  2. History of iodine allergy
  3. History of morphine allergy
  4. Abnormal thyroid hormones.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iodopovidone group
Patients who will be randomized for using iodopovidone solution for pleurodesis.
Drug: Iodopovidone solution
In this group, iodopovidone solution will be used as pleurodesis substance
Other Names:
  • povidone-iodine solution
Active Comparator: Talc group
Patients who will be randomized for using Talc for pleurodesis.
Drug: Talc
In this group, Talc will be used as pleurodesis substance
Other Names:
  • Talcum powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of treatment
Time Frame: 7 days
Success of treatment defined as chest drain can be removed within 1 week after intervention
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of pleural effusion after pleurodesis
Time Frame: Until chest drain removal, an average of 7 days
Observing amount of pleural effusion after intervention comparing between both groups
Until chest drain removal, an average of 7 days
Side effect
Time Frame: with 24 hours after intervention
Side effects are chest pain, fever, and respiratory failure.
with 24 hours after intervention
Length of hospital stay
Time Frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 30 days
From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Apichat Tantraworasin, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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