Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Pleural Effusion

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.

This arm consists of eligible participants who are randomized to control group and would not receive any intervention.

All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.

Talc

Scott Shofer

The purpose of this study is to compare the experiences of subjects who drain malignant (cancerous) pleural effusions (fluid) from around their lung(s) in a more frequent manner using a talc instilled via tunneled pleural catheter combined with daily drainage and those subjects who drain this fluid in a daily standard manner.

Study Activities: Patients will be randomized to either the standard daily drainage group or the talc instilled via tunneled pleural catheter combined with standard daily drainage group. Patients will complete questionnaires regarding their health. If you are randomized to the talc group, you will receive talc infused through the tunneled pleural catheter. If you are randomized to the standard daily drainage group, you will not receive any additional therapy. Patients will complete a drainage diary for everyday they drain fluid which will provide information on drainage volume, fluid color, pain, and complications. At 30 days and 90 days post randomization, patients will return to clinic for follow-up, at which time they will have a physical exam, chest x-ray, and complete questionnaires regarding their health.

Risks/Safety Issues: Risks associated with talc include fever and pain. Less likely risks associated with talc include infection, dyspnea, hypoxemia, pneumonia, unilateral pulmonary edema, hemoptysis, pulmonary emboli, and bronchopleural fistula.

Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion

Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion - The ASAP II Trial

Borg Dyspnea Scale was used to rate difficulty of breathing. This scale starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. Lower scores on this scale equal a better outcome.

Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) was evaluated for overall health status. The SF-36 is composed of eight multi-item scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher qualify of life.

Duke University

This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.

Talc: All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.

Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage

Standard Daily Drainage

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Only participants who underwent pleurodesis while on study are included in the analysis

Percentage of Participants Undergoing Accelerated Pleurodesis

Baseline

Day 30

Day 90

Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit.

Dyspnea as Measured by Questionnaire

Physical functioning

Role limitations due to physical health

Role limitations due to emotional problems

Energy/fatigue

Emotional well-being

Social functioning

Pain

General health

Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline

Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days

Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days

Overall Study

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Blood Substitutes

Micronutrients

Povidone-Iodine

Povidone

Iodine

Cadexomer iodine

Plasma Substitutes

Anti-Infective Agents, Local

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

Patients who will be randomized for using Talc for pleurodesis.

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

Iodopovidone solution

In this group, Talc will be used as pleurodesis substance

Apichat Tantraworasin

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)

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.

Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion

Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion: a Randomized Controlled Trial Study

Success of treatment defined as chest drain can be removed within 1 week after intervention

Observing amount of pleural effusion after intervention comparing between both groups

Side effects are chest pain, fever, and respiratory failure.

Chiang Mai University

Assistant Professor

Symptoms and General Pathology

Neoplasm Metastasis

Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.

Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

talc

dyspnea management

Todd Demmy, MD

RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer.

OBJECTIVES:

* Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small (PleurX) catheter for the treatment of a symptomatic unilateral malignant pleural effusion.
* Compare the 30-day effusion control rate in patients treated with these procedures.
* Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures.
* Compare patient acceptance and satisfaction after treatment with these procedures.
* Compare the level of symptoms and dyspnea experienced by patients treated with these procedures.
* Compare the types, causes, and rates of early technical failures of these procedures in these patients.
* Compare the 30-day effusion recurrences in patients treated with these procedures.
* Compare the 60-day durability of pleurodesis in patients treated with these procedures.
* Compare the mortality, morbidity, and common surgical complications in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to inpatient status (yes vs no), disease type (breast vs lung vs other), and concurrent systemic chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.
* Arm II: Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment.

Patients are followed at 30 and 60 days.

Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer

Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Sclerosis

4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time

4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time

4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time

Jemi Olak, MD

RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc is more effective than dry talc in treating patients with malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion.

OBJECTIVES: I. Compare the proportion of patients with successful pleurodesis at 30 days following treatment for malignant pleural effusion (MPE) by talc slurry via chest tube vs thoracoscopic talc insufflation. II. Compare the cost and cost effectiveness of both treatments for MPE. III. Compare the time to recurrence of effusion, duration of chest tube drainage after sclerosis, extent of postinstillation complications and toxicities, and the ability to re-expand the lung in patients randomized to these 2 treatments. IV. Evaluate the quality of life and pain experienced by patients during both treatments.

OUTLINE: This is a randomized study. Patients are stratified according to participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients undergo pleurodesis. A chest tube is inserted, the pleural fluid is drained for 24 hours, and the lung is re-expanded to at least 90% of full expansion. Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube, which is then clamped. Patients are rotated in all possible directions, holding each position for about 30 minutes. After 2 hours the chest tube is unclamped and reattached to suction drainage, which is strictly measured for 24-hour totals. Following a decrease in drainage to no more than 150 ml/24 hours (usually by the second or third day postsclerosis), the chest tube is removed. Arm II: Patients receive thoracoscopic insufflation. The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization, and the lung is re-expanded to 90% of full expansion. Dry talc is pneumatically insufflated into the chest, with complete dispersion throughout the hemithorax. Following insufflation, the chest is drained via a chest tube, which is removed when the drainage is no more than 150 ml/24 hours (usually by day 2 or 3 following insufflation). Patients are removed from study for disease progression or an unsuccessful lung re-expansion. Patients are followed monthly for 6 months for relapse and survival.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study over 28 months.

Talc in Treating Patients With Malignant Pleural Effusion

Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study

cost and cost effectiveness of treating malignant pleural effusions

Eastern Cooperative Oncology Group

Radiation Therapy Oncology Group

North Central Cancer Treatment Group

Rare Diseases

Recurrence

Mesothelioma

Mesothelioma, Malignant

Lung Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Diseases

Malignant Mesothelioma

Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.

Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

therapeutic thoracoscopy

therapeutic videothoracoscopy

Robert Winter, MD

RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

OBJECTIVES:

Primary

* Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.

Secondary

* Compare the control of pleural effusion in these patients.
* Compare procedure-related complications in these patients.
* Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
* Compare the length of hospital stay for these patients.
* Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
* Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.

* Arm I (video-assisted thoracoscopic \[VAT\] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
* Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.

Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

Papworth Hospital NHS Foundation Trust

Facies

Pneumothorax

Primary Spontaneous Pneumothorax

Pleurodesis with either talc or iodopovidone

Abinash Paul, MD

Ritesh Agarwal, MD DM

Dheeraj Gupta, MD, DM, FCCP

Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is done to get rid of collections of fluid or air in this space. A common reason would be cancer of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this situation it is a palliative procedure to free the patient from symptoms like breathlessness.

Pleurodesis is a technique used to fuse the two layers of the pleura. This is done to prevent reaccumulation of collections of fluid or air in this space. Common indications are malignant pleural effusions, recurrent pneumothorax and even benign effusions which are otherwise difficult to eradicate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion	NCT04792970	Malignant Pleur...	Talc	18 Years -	Duke University
Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion	NCT02674243	Malignant Pleur...	Iodopovidone so... Talc	18 Years -	Chiang Mai University
Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion	NCT02674243	Malignant Pleur...	Iodopovidone so... Talc	18 Years -	Chiang Mai University
Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion	NCT04792970	Malignant Pleur...	Talc	18 Years -	Duke University
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer	NCT00042770	Metastatic Canc... Pulmonary Compl...	talc dyspnea managem...	18 Years -	Alliance for Clinical Trials in Oncology
Talc in Treating Patients With Malignant Pleural Effusion	NCT00002622	Metastatic Canc...	talc Talc	18 Years - 120 Years	Alliance for Clinical Trials in Oncology
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma	NCT00821860	Malignant Mesot... Metastatic Canc...	talc therapeutic tho... therapeutic vid...	18 Years -	Papworth Hospital NHS Foundation Trust
Talc in Treating Patients With Malignant Pleural Effusion	NCT00002622	Metastatic Canc...	talc Talc	18 Years - 120 Years	Alliance for Clinical Trials in Oncology
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis	NCT00430664	Malignant Pleur... Recurrent Pleur... Primary Spontan... Secondary Spont...	Pleurodesis wit...	12 Years -	PIMERIndia
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis	NCT00430664	Malignant Pleur... Recurrent Pleur... Primary Spontan... Secondary Spont...	Pleurodesis wit...	12 Years -	PIMERIndia

Spots Global Cancer Trial Database for talc

Every month we try and update this database with for talc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for talc

Every month we try and update this database with for talc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for talc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.