Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion
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| ClinicalTrials.gov Identifier: NCT02674243 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Pleural Effusion | Drug: Iodopovidone solution Drug: Talc | Phase 3 |
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 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 |
|---|---|
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Experimental: Iodopovidone group
Patients who will be randomized for using iodopovidone solution for pleurodesis.
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Drug: Iodopovidone solution
In this group, iodopovidone solution will be used as pleurodesis substance
Other Name: povidone-iodine solution |
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Active Comparator: Talc group
Patients who will be randomized for using Talc for pleurodesis.
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Drug: Talc
In this group, Talc will be used as pleurodesis substance
Other Name: Talcum powder |
- Success of treatment [ Time Frame: 7 days ]Success of treatment defined as chest drain can be removed within 1 week after intervention
- 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
- Side effect [ Time Frame: with 24 hours after intervention ]Side effects are chest pain, fever, and respiratory failure.
- 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 |
Inclusion Criteria:
- All MPE proved by cytology
- After pleural effusion was released by chest tube drainage, lung was fully expanded
Exclusion Criteria:
- Patients who have Karnofsky performance state ≤ 40
- History of iodine allergy
- History of morphine allergy
- Abnormal thyroid hormones.
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
| Contact: Apichat Tantraworasin, M.D, Ph.D. | 6653945767 | ohm_med@hotmail.com |
| 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. | |
| Principal Investigator: | Apichat Tantraworasin | Chiang Mai University |
| 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 |
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Malignant pleural effusion Pleurodesis Talc Iodopovidone solution Povidone-iodine |
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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 |