Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674243
• Other study ID #: 03315
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Iodopovidone solution
In this group, iodopovidone solution will be used as pleurodesis substance
• Talc
In this group, Talc will be used as pleurodesis substance

Locations

Country	Name	City	State
Thailand	Department of surgery, Faculty of medicine, Chiang Mai University Hospital	Chiang Mai	Chaing Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of treatment	Success of treatment defined as chest drain can be removed within 1 week after intervention	7 days
Secondary	Amount of pleural effusion after pleurodesis	Observing amount of pleural effusion after intervention comparing between both groups	Until chest drain removal, an average of 7 days
Secondary	Side effect	Side effects are chest pain, fever, and respiratory failure.	with 24 hours after intervention
Secondary	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