Malignant Pleural EffusionTIME-1NCT00896285
The First Therapeutic Intervention in Malignant Pleural Effusion Trial
A study testing Large bore chest drain + NSAID based analgesic regimen, Small bore chest drain + NSAID based analgesic regimen and Large bore chest drain + opiate based analgesic regimen in people with Malignant Pleural Effusion and Pleural Effusion, run by University of California, Davis at 1 site in United States.
Trial summary
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Pleural Effusion
- What is being tested?
- Large bore chest drain + NSAID based analgesic regimen, Small bore chest drain + NSAID based analgesic regimen and Large bore chest drain + opiate based analgesic regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2014
- 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
- Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
- Histologically proven pleural malignancy OR
- Typical features of pleural malignancy seen on direct vision during thoracoscopy OR
- Pleural effusion in the context of histologically proven cancer elsewhere
- Expected survival more than 1 month
- Written informed consent
Who cannot join
- Age < 18 years
- Primary lymphoma or small cell lung carcinoma
- Patients who are pregnant or lactating
- Inability to give informed consent
- History of GI bleeding or of untreated peptic ulceration
- Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen
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- Hypercapnic respiratory failure
- Known intravenous drug abuse
- Severe renal or liver disease
- Known bleeding diathesis
- Warfarin therapy
- Current or recent (within 2 weeks) corticosteroid steroid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.
The investigators hope to find the best way to prevent pain during pleurodesis.
Read the detailed description
Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. Talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. This procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. Reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure.
This trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. It will also address whether either of these influences success rate of pleurodesis.
We hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. We hope to find the best way of preventing pain during this procedure.
- Conditions
- Malignant Pleural Effusion, Pleural Effusion
- Being tested
- Large bore chest drain + NSAID based analgesic regimen, Small bore chest drain + NSAID based analgesic regimen, Large bore chest drain + opiate based analgesic regimen, Small bore chest drain + opiate based analgesic regimen
- Keywords
- Pleural malignancy, pleural effusion, pleurodesis, chest tube, cancer, cancer pain management
- Medical subject headings
- Pleural Effusion, Malignant, Pleural Effusion, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large bore chest drain + NSAID based analgesic regimenOther
Chest tube greater than 14 French size and ibuprofen.
Small bore chest drain + NSAID based analgesic regimenOther
Chest tube less than or equal to 14 French size and ibuprofen.
Large bore chest drain + opiate based analgesic regimenOther
Chest tube greater than 14 French size and morphine.
Small bore chest drain + opiate based analgesic regimenOther
Chest tube less than or equal to 14 French size and morphine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: Large bore chest drain + NSAID based analgesic regimen |
| 2 | Active comparator | Not described Receives: Other: Small bore chest drain + NSAID based analgesic regimen |
| 3 | Active comparator | Not described Receives: Other: Large bore chest drain + opiate based analgesic regimen |
| 4 | Active comparator | Not described Receives: Other: Small bore chest drain + opiate based analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
An average pain score over 72 hours post pleurodesis for malignant pleural effusion
Measured: 72 hours
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)
Measured: 3 months
Secondary outcomes (2)
Presence of chronic chest pain on the side of the pleurodesis
Measured: 6 weeks
Presence of chronic chest pain on the side of the pleurodesis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RJO Davies, Dr., Principal investigator, Oxford Pleural Unit, Churchill Hospital, Oxford, England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896285
- Sponsor's protocol ID
- 200816478
- Acronym
- TIME-1
- Status last verified
- Jul 2015
- First submitted
- 7 May 2009
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
- ClinicalTrials.gov ID
- NCT00896285
- Acronym / sponsor ID
- TIME-1 / 200816478
- Conditions
- Malignant Pleural Effusion, Pleural Effusion
- Keywords
- Pleural malignancy, pleural effusion, pleurodesis, chest tube, cancer, cancer pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 May 2009 (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.
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.
The investigators hope to find the best way to prevent pain during pleurodesis.
Detailed description
Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. Talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. This procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. Reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure.
This trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. It will also address whether either of these influences success rate of pleurodesis.
We hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. We hope to find the best way of preventing pain during this procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Large bore chest drain + NSAID based analgesic regimen |
| 2 | Active comparator | Other: Small bore chest drain + NSAID based analgesic regimen |
| 3 | Active comparator | Other: Large bore chest drain + opiate based analgesic regimen |
| 4 | Active comparator | Other: Small bore chest drain + opiate based analgesic regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
- Expected survival more than 1 month
- Written informed consent
Key exclusion criteria (12 listed)
- Age < 18 years
- Primary lymphoma or small cell lung carcinoma
- Patients who are pregnant or lactating
- Inability to give informed consent
- History of GI bleeding or of untreated peptic ulceration
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 |
|---|---|---|
| Large bore chest drain + NSAID based analgesic regimenChest tube greater than 14 French size and ibuprofen. | Other | 1 |
| Small bore chest drain + NSAID based analgesic regimenChest tube less than or equal to 14 French size and ibuprofen. | Other | 2 |
| Large bore chest drain + opiate based analgesic regimenChest tube greater than 14 French size and morphine. | Other | 3 |
| Small bore chest drain + opiate based analgesic regimenChest tube less than or equal to 14 French size and morphine. | Other | 4 |
Primary outcome
An average pain score over 72 hours post pleurodesis for malignant pleural effusion
Time frame: 72 hours
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)
Time frame: 3 months
2 secondary outcomes
Presence of chronic chest pain on the side of the pleurodesis
Time frame: 6 weeks
Presence of chronic chest pain on the side of the pleurodesis
Time frame: 6 months
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 20 Jul 2015.
Related trials for Malignant Pleural Effusion
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RecruitingObservational study
UNC Pleural Fluid Registry
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Intrapleural Catheter Daily Versus Three Times a Week Drainage
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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.
RJO Davies, Dr. principal investigator
Oxford Pleural Unit, Churchill Hospital, Oxford, England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large bore chest drain + NSAID based analgesic regimen, Small bore chest drain + NSAID based analgesic regimen and Large bore chest drain + opiate based analgesic regimen in people with Malignant Pleural Effusion and Pleural Effusion, run by University of California, Davis 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 6 inclusion and 12 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 20 Jul 2015. 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.
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?
An average pain score over 72 hours post pleurodesis for malignant pleural effusion (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 20 Jul 2015.