Malignant Pleural Effusion
Conditions
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.
Interventions
DRUGTalc
All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true: 1. There is histocytological confirmation of pleural malignancy 2. 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. 3. 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. 4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls. 6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. 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
1. 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: 1. A CXR shows hydropneumothorax other than small (\< 1 cm between chest wall and pleural line) apical pneumothoraces. 2. 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. 3. 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). 2. 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. 3. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Undergoing Accelerated Pleurodesis | Up to 90 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea as Measured by Questionnaire | Baseline, 30 days, 90 Days | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Standard Daily Drainage This arm consists of eligible participants who are randomized to control group and would not receive any intervention. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Standard Daily Drainage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 |
Outcome results
Primary
Percentage of Participants Undergoing Accelerated Pleurodesis
Time frame: Up to 90 Days
Population: Only participants who underwent pleurodesis while on study are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Daily Drainage | Percentage of Participants Undergoing Accelerated Pleurodesis | 100 percentage of participants |
Secondary
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.
Time frame: Baseline, 30 days, 90 Days
Population: Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Dyspnea as Measured by Questionnaire | Baseline | 2 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Dyspnea as Measured by Questionnaire | Day 30 | 2 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Dyspnea as Measured by Questionnaire | Day 90 | 0 score on a scale |
| Standard Daily Drainage | Dyspnea as Measured by Questionnaire | Baseline | 0.5 score on a scale |
| Standard Daily Drainage | Dyspnea as Measured by Questionnaire | Day 30 | 1 score on a scale |
Secondary
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.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Physical functioning | 25 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Energy/fatigue | 45 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Emotional well-being | 60 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Social functioning | 62.5 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Pain | 90 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | General health | 35 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | General health | 35 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Physical functioning | 5 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Emotional well-being | 60 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Role limitations due to physical health | 0 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Pain | 32.5 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Role limitations due to emotional problems | 0 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Social functioning | 25 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | Energy/fatigue | 40 score on a scale |
Secondary
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.
Time frame: 90 days
Population: Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | Social functioning | 50 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | Energy/fatigue | 0 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | Physical functioning | 5 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | Emotional well-being | 84 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | Pain | 62.5 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | General health | 35 score on a scale |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Physical functioning | 30 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Emotional well-being | 56 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Social functioning | 50 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 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 |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Pain | 62.5 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | General health | 30 score on a scale |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Energy/fatigue | 50 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | General health | 20 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Physical functioning | 25 score on a scale |
| Standard Daily Drainage | 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 |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Role limitations due to emotional problems | 0 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Energy/fatigue | 25 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Emotional well-being | 72 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Social functioning | 25 score on a scale |
| Standard Daily Drainage | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Pain | 0 score on a scale |