Back to resultsRandomized 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
Primary Purpose
Malignant Pleural Effusion
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Talc
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
- Male or female, at least 18 years of age, inclusive.
Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:
- There is histocytological confirmation of pleural malignancy
- The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.
- Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
- Subject is willing and able to provide written informed consent.
- Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
- Subject has sufficient pleural fluid to allow safe insertion of an IPC.
- Subject has negative pregnancy test if appropriate.
- Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member, or paid healthcare professional).
Exclusion Criteria:
Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, two separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after tunneled pleural catheter insertion. Significant trapped lung is deemed present if any 1 of the following criteria is met:
- A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and pleural line) apical pneumothoraces.
- A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
- A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).
- Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.
- Subject is pregnant, planning to become pregnant, or is lactating.
- Subject has a history of empyema.
- Subject has a history of chylothorax.
- Subject has an uncorrected coagulopathy.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Talc instilled via tunneled pleural catheter combined with standard daily drainage
Standard daily drainage
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Undergoing Accelerated Pleurodesis
Secondary Outcome Measures
Dyspnea as Measured by Questionnaire
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.
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
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.
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
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.
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04792970
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Study enrollment not met
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Talc instilled via tunneled pleural catheter combined with standard daily drainage
Arm Type
Active Comparator
Arm Description
This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.
Arm Title
Standard daily drainage
Arm Type
No Intervention
Arm Description
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
Intervention Type
Drug
Intervention Name(s)
Talc
Intervention Description
All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.
Primary Outcome Measure Information:
Title
Percentage of Participants Undergoing Accelerated Pleurodesis
Time Frame
Up to 90 Days
Secondary Outcome Measure Information:
Title
Dyspnea as Measured by Questionnaire
Description
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.
Time Frame
Baseline, 30 days, 90 Days
Title
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Description
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.
Time Frame
Baseline
Title
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Description
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.
Time Frame
30 days
Title
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, at least 18 years of age, inclusive.
Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:
There is histocytological confirmation of pleural malignancy
The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.
Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
Subject is willing and able to provide written informed consent.
Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
Subject has sufficient pleural fluid to allow safe insertion of an IPC.
Subject has negative pregnancy test if appropriate.
Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member, or paid healthcare professional).
Exclusion Criteria:
Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, two separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after tunneled pleural catheter insertion. Significant trapped lung is deemed present if any 1 of the following criteria is met:
A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and pleural line) apical pneumothoraces.
A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).
Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.
Subject is pregnant, planning to become pregnant, or is lactating.
Subject has a history of empyema.
Subject has a history of chylothorax.
Subject has an uncorrected coagulopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Shofer
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27898215
Citation
Wahidi MM, Reddy C, Yarmus L, Feller-Kopman D, Musani A, Shepherd RW, Lee H, Bechara R, Lamb C, Shofer S, Mahmood K, Michaud G, Puchalski J, Rafeq S, Cattaneo SM, Mullon J, Leh S, Mayse M, Thomas SM, Peterson B, Light RW. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1050-1057. doi: 10.1164/rccm.201607-1404OC.
Results Reference
background
PubMed Identifier
29617585
Citation
Bhatnagar R, Keenan EK, Morley AJ, Kahan BC, Stanton AE, Haris M, Harrison RN, Mustafa RA, Bishop LJ, Ahmed L, West A, Holme J, Evison M, Munavvar M, Sivasothy P, Herre J, Cooper D, Roberts M, Guhan A, Hooper C, Walters J, Saba TS, Chakrabarti B, Gunatilake S, Psallidas I, Walker SP, Bibby AC, Smith S, Stadon LJ, Zahan-Evans NJ, Lee YCG, Harvey JE, Rahman NM, Miller RF, Maskell NA. Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion. N Engl J Med. 2018 Apr 5;378(14):1313-1322. doi: 10.1056/NEJMoa1716883.
Results Reference
background
Learn more about this trial
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
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