Pleural Effusion, MalignantOPTIMUMNCT02517749
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
A study testing Chest Drain Insertion and Talc Pleurodesis and Indwelling Pleural Catheter Insertion and Talc Pleurodesis in people with Pleural Effusion, Malignant, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- Chest Drain Insertion and Talc Pleurodesis and Indwelling Pleural Catheter Insertion and Talc Pleurodesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of malignant pleural effusion
- WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
- Expected survival greater than 3 months
Who cannot join
- Age less than 18 years old
- Pregnant or lactating
- Known allergy to Talc or Lignocaine
- Lack of symptomatic relief from effusion drainage
- At least twice weekly drainage cannot be undertaken
- Lymphoma or small cell carcinoma except*:
Show all 11Show fewer
- Failure of chemotherapy
- Deemed for palliative management
- Non malignant effusions
- Loculated pleural effusion
- Unable to provide written informed consent to trial participation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient Management in Improving Health Related Quality of Life
This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention
- Conditions
- Pleural Effusion, Malignant
- Being tested
- Chest Drain Insertion and Talc Pleurodesis, Indwelling Pleural Catheter Insertion and Talc Pleurodesis
- 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.
Chest Drain Insertion and Talc PleurodesisDevice
Indwelling Pleural Catheter Insertion and Talc PleurodesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc Receives: Device: Chest Drain Insertion and Talc Pleurodesis |
| Indwelling Pleural Catheter Group | Active comparator | Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc Receives: Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global health-related quality of life
Global health related quality of life as measured by EORTC QLQ-C30
Measured: 30 days
Secondary outcomes (4)
Global health-related quality of life
Measured: 60 and 90 days
Pleurodesis failure rate
Subsequent pleural intervention required on same side as pleurodesis
Chest X-ray opacification greater than 25% on side of intervention
Measured: 30, 60 and 90 days
Improvement in symptoms of pain and breathlessness
Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness
Measured: 30, 60 and 90 days
Complication rate
Clinical review and adverse event documentation
Measured: Day 7, 14, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517749
- Sponsor's protocol ID
- RJ115/N175
- Acronym
- OPTIMUM
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2015
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient Management in Improving Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT02517749
- Acronym / sponsor ID
- OPTIMUM / RJ115/N175
- Conditions
- Pleural Effusion, Malignant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Device: Chest Drain Insertion and Talc PleurodesisPatients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc |
| Indwelling Pleural Catheter Group | Active comparator | Device: Indwelling Pleural Catheter Insertion and Talc PleurodesisPatients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of malignant pleural effusion
- WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
- Expected survival greater than 3 months
Key exclusion criteria (11 listed)
- Age less than 18 years old
- Pregnant or lactating
- Known allergy to Talc or Lignocaine
- Lack of symptomatic relief from effusion drainage
- At least twice weekly drainage cannot be undertaken
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 |
|---|---|---|
| Chest Drain Insertion and Talc Pleurodesis | Device | Usual Care Group |
| Indwelling Pleural Catheter Insertion and Talc Pleurodesis | Device | Indwelling Pleural Catheter Group |
Primary outcome
Global health-related quality of life
Time frame: 30 days
Global health related quality of life as measured by EORTC QLQ-C30
4 secondary outcomes
Global health-related quality of life
Time frame: 60 and 90 days
Pleurodesis failure rate
Time frame: 30, 60 and 90 days
Improvement in symptoms of pain and breathlessness
Time frame: 30, 60 and 90 days
Complication rate
Time frame: Day 7, 14, 30, 60 and 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Related trials for Pleural Effusion, Malignant
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Drain Insertion and Talc Pleurodesis and Indwelling Pleural Catheter Insertion and Talc Pleurodesis in people with Pleural Effusion, Malignant, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 24 Nov 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 Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global health-related quality of life (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.