Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

NCT ID: NCT02674243

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-12-31

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)

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.

Conditions

Malignant Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Iodopovidone group

Patients who will be randomized for using iodopovidone solution for pleurodesis.

Group Type: EXPERIMENTAL

Iodopovidone solution

Intervention Type: DRUG

In this group, iodopovidone solution will be used as pleurodesis substance

Talc group

Patients who will be randomized for using Talc for pleurodesis.

Group Type: ACTIVE_COMPARATOR

Talc

Intervention Type: DRUG

In this group, Talc will be used as pleurodesis substance

Interventions

Iodopovidone solution

In this group, iodopovidone solution will be used as pleurodesis substance

Intervention Type: DRUG

Talc

In this group, Talc will be used as pleurodesis substance

Intervention Type: DRUG

Other Intervention Names

povidone-iodine solution; Talcum powder

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Apichat Tantraworasin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Apichat Tantraworasin

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Chiang Mai, Chaing Mai, Thailand

Countries

Thailand

Other Identifiers

03315

Identifier Type: -

Identifier Source: org_study_id