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Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

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ClinicalTrials.gov Identifier: NCT02674243
Recruitment Status : Unknown
Verified February 2017 by Apichat Tantraworasin, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : February 4, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Apichat Tantraworasin, Chiang Mai University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

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 Name: 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 Name: Talcum powder




Primary Outcome Measures :
  1. Success of treatment [ Time Frame: 7 days ]
    Success of treatment defined as chest drain can be removed within 1 week after intervention


Secondary Outcome Measures :
  1. 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

  2. Side effect [ Time Frame: with 24 hours after intervention ]
    Side effects are chest pain, fever, and respiratory failure.

  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674243


Contacts
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Contact: Apichat Tantraworasin, M.D, Ph.D. 6653945767 ohm_med@hotmail.com

Locations
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Thailand
Department of surgery, Faculty of medicine, Chiang Mai University Hospital Recruiting
Amphoe Meung, Chaing Mai, Thailand, 50200
Contact: Apichat Tantraworasin, M.D., Ph.D.    +66896336342    ohm_med@hotmail.com   
Principal Investigator: Apichat Tantraworasin, M.D., Ph.D.         
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Apichat Tantraworasin Chiang Mai University

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Responsible Party: Apichat Tantraworasin, Assistant Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02674243     History of Changes
Other Study ID Numbers: 03315
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Apichat Tantraworasin, Chiang Mai University:
Malignant pleural effusion
Pleurodesis
Talc
Iodopovidone solution
Povidone-iodine
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Povidone-Iodine
Povidone
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Plasma Substitutes
Blood Substitutes