Plain English Summary
Trial website
Additional identifiers
EudraCT number
2005-005226-31
ClinicalTrials.gov number
NCT00644319
Protocol/serial number
1.1
Study information
Scientific title
The first Therapeutic Interventions in Malignant Effusion trial
Acronym
TIME1
Study hypothesis
The TIME1 study is a 2 x 2 randomised factorial trial to assess whether non-steroidal (ibuprofen) analgesia and the use of small bore chest tubes will reduce pain during pleurodesis for malignant effusion, compared to standard care. The trial will also define whether non-steroidal use decreases pleurodesis efficacy.
Ethics approval
West Essex Local Research Ethics Committee, 24/04/2006, ref: 05/Q0301/61
Study design
2 x 2 randomised factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malignant pleural effusion, including mesothelioma
Intervention
Participants will undergo normal care (thoracoscopy and talc poudrage or talc slurry pleurodesis via drain), using standardised pre-procedure sedation and analgesia as per protocol. The sizes of chest tubes to be used are predefined (large [24F] and small [12F]). The analgesic regimens are:
1. NSAID: ibuprofen 800 mg three times daily (tds) to a maximum of 8-hourly
2. Opiate: diamorphine 2.5 mg, intravenous (IV) administration, four times daily (qds) to a maximum of 10 mg
3. Rescue: patients will always have access to rescue analgesia as required (diamorphine 2.5 mg IV)
Treatment continues from pleurodesis (day 0) to tube removal (day 3).
Participants will be randomised to one of the following arms:
1. Large bore (24F) chest drain and NSAID-based analgesic regimen
2. Small bore (12F) chest drain and NSAID-based analgesic regimen
3. Large bore chest drain (24F) and opiate-based analgesic regimen
4. Small bore chest drain (12F) and opiate-based analgesic regimen
Intervention type
Drug
Phase
Not Applicable
Drug names
Ibuprofen
Primary outcome measures
Pain score over 72 hours post pleurodesis for malignant pleural effusion, taken by administering 100 mm visual analogue pain score (VAS), to calculate the total pain relief (TOTPAR) score, over 3 days
Secondary outcome measures
1. Success of pleurodesis at six weeks and three months post randomisation (time to relapse of pleural effusion, survival analysis)
2. Presence of chronic chest pain on the side of the pleurodesis at six weeks and three months post randomisation
Overall trial start date
26/03/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis
Definitions:
1.1. Histologically proven pleural malignancy
1.2. Typical features of pleural malignancy seen on direct vision during thoracoscopy
1.3. Pleural effusion in the context of histologically proven cancer elsewhere
2. Written informed consent
3. Expected survival more than one month
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320 (interim analysis after 120 patients)
Participant exclusion criteria
1. Age less than 18 years
2. Primary lymphoma or small cell lung carcinoma
3. Patients who are pregnant or lactating
4. Inability to give informed consent
5. History of gastrointestinal (GI) bleeding or of untreated peptic ulceration
6. Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or opiates
7. Hypercapnic ventilatory failure
8. Known intravenous drug abuse
9. Severe renal or liver disease
10. Known bleeding diathesis
11. Warfarin therapy which must be continued
12. Current or recent (within two weeks) corticosteroid steroid therapy
Recruitment start date
26/03/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
Funders
Funder type
University/education
Funder name
University of Oxford (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26720026