Clinical trial NCT02674243: Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion
Official title: Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion: a Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Pleural Effusion
Keywords: Malignant pleural effusion
Pleurodesis
Talc
Iodopovidone solution
Povidone-iodine
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success of treatment
timeFrame: 7 days
Secondary outcomes:
measure: Amount of pleural effusion after pleurodesis
timeFrame: Until chest drain removal, an average of 7 days
measure: Side effect
timeFrame: with 24 hours after intervention
measure: Length of hospital stay
timeFrame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 30 days
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of surgery, Faculty of medicine, Chiang Mai University Hospital
state: Chaing Mai
Study officials:
affiliation: Chiang Mai University
name: Apichat Tantraworasin
role: PRINCIPAL_INVESTIGATOR
References: