Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

Sponsor

Chiang Mai University (Other)

Overall Status

Completed

CT.gov ID

NCT02674243

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Malignant Pleural Effusion	Drug: Iodopovidone solution Drug: Talc	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Success of treatment [7 days]
Success of treatment defined as chest drain can be removed within 1 week after intervention

Secondary Outcome Measures

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