Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02674243
Other study ID # 03315
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00052338 - Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06421610 - OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion. Phase 1
Recruiting NCT04793607 - Interventions for Malignant Pleural Effusions Impact on Fatigue
Recruiting NCT03987087 - A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC Phase 2
Recruiting NCT02942043 - Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer Phase 2
Completed NCT01997190 - Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Phase 1
Completed NCT00564733 - FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Phase 2
Not yet recruiting NCT04131231 - Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion N/A
Terminated NCT01004510 - Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT00313066 - Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Phase 4
Terminated NCT04236037 - Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura N/A
Completed NCT05372055 - Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Not yet recruiting NCT04914598 - A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions Phase 3
Recruiting NCT04322136 - AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion N/A
Recruiting NCT03973957 - Talc Outpatient Pleurodesis With Indwelling Catheter N/A
Recruiting NCT05923515 - A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Phase 1
Completed NCT02649894 - Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter N/A
Recruiting NCT03403855 - Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients N/A
Terminated NCT03597009 - A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion Phase 1/Phase 2