Condition category
Cancer
Date applied
10/02/2016
Date assigned
10/02/2016
Last edited
09/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Ioannis Psallidas

ORCID ID

Contact details

Respiratory Medicine Unit
NDM Research Building
University of Oxford
Old Road Campus
Oxford
OX3 7FZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20343

Study information

Scientific title

The efficacy of Sonographic and bIological pleurodesis indicators of Malignant PLeural Effusion (SIMPLE) -­ A randomised trial

Acronym

SIMPLE

Study hypothesis

The aim of this trial is to:
1. Establish if a novel radiological investigation (thoracic ultrasound) can improve quality and efficacy of care for MPE patients undergoing talc pleurodesis
2. Establish a biobank of prospectively collected biological samples and radiology in patients undergoing talc pleurodesis, linked to robust outcome data, to investigate factors associated with pleurodesis “success” and redefine the current understanding in a patient centred model

Ethics approval

12/11/2015, ref: 15/SC/0600

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer, Respiratory disorders; Subtopic: Lung Cancer, Respiratory (all Subtopics); Disease: Lung (small cell), Lung (non-small cell), Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Mesothelioma, Respiratory, Lymphoma (Non Hodgkins - aggressive), Lymphoma (Non Hodgkins - indolent), Lymphoma (other)

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants receive thoracic ultrasound imaging before and post talc administration.

Control group: Participants receive talc pleurodesis with no thoracic ultrasound imaging.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Length of hospital stay (in days) during the initial hospitalisation.

Secondary outcome measures

1. Mortality rate is recorded at 12 months
2. Number of days in hospital post-randomisation with drain in situ
3. Patient reported dysponea/chest pain post-randomisation is measured through daily assessments for 7 days and then weekly for 4 weeks
4. Patient reported quality of life is measured using the EQ-5D-5L questionnaire at baseline, 1 and 3 months
5. Pleurodesis success is determined at 1 and 3 months
6. Use of healthcare resources and costs using utilisation logs is measured as discharge, 1 and 3 months

Overall trial start date

14/12/2015

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinically confident diagnosis of MPE requiring pleurodesis defined as any of the following (more than one can be included):
1.1. Histocytologically proven MPE
1.2. Thoracic CT evidence of pleural malignancy
1.3. Otherwise unexplained exudative effusion in the context of clinically proven cancer elsewhere
2. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 262; UK Sample Size: 262

Participant exclusion criteria

1. Aged under 18 years
2. Poor prognosis (pleurodesis not offered in normal practice)
3. Irreversible contra-indication to drain insertion

Recruitment start date

14/12/2015

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Respiratory Medicine Unit NDM Research Building Nuffield Department of Medicine Old Road Campus
Oxford
OX3 7FZ
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

09/06/2016: Link to Cancer Help UK lay summary added.