Condition category
Cancer
Date applied
11/03/2006
Date assigned
19/04/2006
Last edited
04/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Robert Davies

ORCID ID

Contact details

Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

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

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o Heather House
Head of Clinical Trials Office
University of Oxford
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

On 01/05/2008 the overall trial start and end dates were updated Previous overall trial start date: 01/09/2006 Previous overall trial end date: 01/09/2008 On 22/02/2011 the overall trial end date was updated Previous overall trial end date: 31/12/2009