Trial Outcomes & Findings for 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 (NCT NCT04792970)
NCT ID: NCT04792970
Last Updated: 2023-09-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
Up to 90 Days
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
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.
|
Standard Daily Drainage
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=2 Participants
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.
|
Standard Daily Drainage
n=2 Participants
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 90 DaysPopulation: Only participants who underwent pleurodesis while on study are included in the analysis
Outcome measures
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
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.
|
Standard Daily Drainage
n=1 Participants
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Percentage of Participants Undergoing Accelerated Pleurodesis
|
—
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 DaysPopulation: Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit.
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.
Outcome measures
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=1 Participants
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.
|
Standard Daily Drainage
n=1 Participants
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Dyspnea as Measured by Questionnaire
Baseline
|
2 score on a scale
|
0.5 score on a scale
|
|
Dyspnea as Measured by Questionnaire
Day 30
|
2 score on a scale
|
1 score on a scale
|
|
Dyspnea as Measured by Questionnaire
Day 90
|
0 score on a scale
|
—
|
SECONDARY outcome
Timeframe: BaselineMedical 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.
Outcome measures
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=1 Participants
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.
|
Standard Daily Drainage
n=1 Participants
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Physical functioning
|
30 score on a scale
|
25 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Role limitations due to physical health
|
0 score on a scale
|
0 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Role limitations due to emotional problems
|
33.3 score on a scale
|
0 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Energy/fatigue
|
50 score on a scale
|
25 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Emotional well-being
|
56 score on a scale
|
72 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Social functioning
|
50 score on a scale
|
25 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
Pain
|
62.5 score on a scale
|
0 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline
General health
|
30 score on a scale
|
20 score on a scale
|
SECONDARY outcome
Timeframe: 30 daysMedical 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.
Outcome measures
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=1 Participants
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.
|
Standard Daily Drainage
n=1 Participants
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Physical functioning
|
25 score on a scale
|
5 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Role limitations due to physical health
|
25 score on a scale
|
0 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Role limitations due to emotional problems
|
33.3 score on a scale
|
0 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Energy/fatigue
|
45 score on a scale
|
40 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Emotional well-being
|
60 score on a scale
|
60 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Social functioning
|
62.5 score on a scale
|
25 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Pain
|
90 score on a scale
|
32.5 score on a scale
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
General health
|
35 score on a scale
|
35 score on a scale
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit.
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.
Outcome measures
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=1 Participants
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.
|
Standard Daily Drainage
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Emotional well-being
|
84 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Physical functioning
|
5 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Role limitations due to physical health
|
0 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Role limitations due to emotional problems
|
33.3 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Energy/fatigue
|
0 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Social functioning
|
50 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
Pain
|
62.5 score on a scale
|
—
|
|
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
General health
|
35 score on a scale
|
—
|
Adverse Events
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Daily Drainage
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=2 participants at risk
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.
|
Standard Daily Drainage
n=2 participants at risk
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Suspected Pleural Catheter Infection
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage
n=2 participants at risk
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.
|
Standard Daily Drainage
n=2 participants at risk
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Catheter Occlusion
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Shortness of Breath
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place