Malignant Pleural EffusionPhase 4NCT04792970
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
A Phase 4 study testing Talc in people with Malignant Pleural Effusion, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Talc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 7 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Subject has a history of empyema.
- Subject has a history of chylothorax.
- Subject has an uncorrected coagulopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
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.
Read the 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.
- Conditions
- Malignant Pleural Effusion
- Being tested
- Talc
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalcDrug
All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.
| Study group | Role | What they receive |
|---|---|---|
| Talc instilled via tunneled pleural catheter combined with standard daily drainage | Active comparator | This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter. Receives: Drug: Talc |
| Standard daily drainage | No intervention | This arm consists of eligible participants who are randomized to control group and would not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Undergoing Accelerated Pleurodesis
Measured: Up to 90 Days
Secondary outcomes (4)
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.
Measured: Baseline, 30 days, 90 Days
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.
Measured: Baseline
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.
Measured: 30 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start18 Mar 2021
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Why it stopped: Study enrollment not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Shofer, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792970
- Sponsor's protocol ID
- Pro00107258
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2021
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27898215Bhatnagar 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.
PubMed 29617585
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04792970
- Acronym / sponsor ID
- Pro00107258
- Conditions
- Malignant Pleural Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment not met
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talc instilled via tunneled pleural catheter combined with standard daily drainage | Active comparator | Drug: TalcThis arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter. |
| Standard daily drainage | No intervention | –This arm consists of eligible participants who are randomized to control group and would not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalcAll patients randomized to the Talc arm will receive Talc therapy through the pleural catheter. | Drug | Talc instilled via tunneled pleural catheter combined with standard daily drainage |
Primary outcome
Percentage of Participants Undergoing Accelerated Pleurodesis
Time frame: Up to 90 Days
4 secondary outcomes
Dyspnea as Measured by Questionnaire
Time frame: Baseline, 30 days, 90 Days
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Time frame: Baseline
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Time frame: 30 days
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27898215Wahidi 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.
- Background: PubMed 29617585Bhatnagar 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.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Shofer principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Talc in people with Malignant Pleural Effusion, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Undergoing Accelerated Pleurodesis (time frame: Up to 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792970, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.