Condition category
Cancer
Date applied
30/09/2015
Date assigned
30/09/2015
Last edited
01/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Parthipan Sivakumar

ORCID ID

http://orcid.org/0000-0003-3740-2612

Contact details

St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Type

Scientific

Additional contact

Dr Liju Ahmed

ORCID ID

http://orcid.org/0000-0001-7722-8829

Contact details

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 7188
liju.ahmed@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19615

Study information

Scientific 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

Acronym

OPTIMUM

Study hypothesis

The aim of the study is to investigate whether a better health related quality of life can be achieved with an indwelling pleural catheter and talc pleurodesis in managing malignant pleural effusion.

Ethics approval

First Medical Research Ethics Committee, 22/06/2015, ref: 15/LO/1018

Study design

Single-centre randomised parallel 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 to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (non-small cell)

Intervention

Participants are randomly allocated into two groups.

Standard care arm: Participants undergo ultrasound guided 12F seldinger chest drain insertion and care as per the British Thoracic Society Guidelines. They will remain as an inpatient following chest drain insertion for drainage and instillation of talc pleurodesis. They will then undergo follow up at Day 7, 14, 30, 60 , 90 with ultrasound, chest X-ray and quality of life and symptom questionnaires

Pleural catheter arm: Participants undergo ultrasound guided insertion of an indwelling pleural catheter. They will then be discharged and brought for follow up to assess for trapped lung. In the absence of trapped lung, patients will undergo talc pleurodesis on Day 4 with a view to drain removal on day 14. Patients will have follow up on day 30,60 and 90.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Health-related quality of life, measured using the EORTC QLQ-C30 questionnaire at baseline, 7, 14 and 30 days

Secondary outcome measures

1. Health-related quality of life, measured using the EORTC QLQ-C30 questionnaire at 60 and 90 days
2. Pleurodesis failure rate, measured using chest X-rays at baseline, 1, between 2-5, 7, 14, 30, 60 and 90 days
3. Improvement in symptoms of pain and breathlessness, measured using the visual analogue scale (VAS) and MRC dyspnea score at baseline, 7, 14, 30, 60 and 90 days
4. Complication rate

Overall trial start date

29/07/2015

Overall trial end date

27/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or over
2. Diagnosis of malignant pleural effusion
3. WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
4. Expected survival greater than 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 142; UK Sample Size: 142

Participant exclusion criteria

1. Aged less than 18 years old
2. Pregnant or lactating
3. Known allergy to Talc or Lignocaine
4. Lack of symptomatic relief from effusion drainage
5. At least twice weekly drainage cannot be undertaken
6. Lymphoma or small cell carcinoma except*:
6.1. Failure of chemotherapy
6.2. Deemed for palliative management
7. Non malignant effusions
8. Loculated pleural effusion
9. Unable to provide written informed consent to trial participation

*Lymphoma and small cell carcinoma are particularly sensitive to treatment with chemotherapeutic agents. If patients have undergone chemotherapy with no treatment response or deemed not for chemotherapy and for palliative management then they will be suitable for inclusion in the study. Liason with the patient’s oncologist or MDT discussion will be required to ascertain this.

Recruitment start date

29/07/2015

Recruitment end date

27/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's & St Thomas' NHS Foundation Trust

Sponsor details

Department of Respiratory Medicine
First Floor Lambeth Wing
St Thomas’ Hospital
Westminster Bridge Road
Lonodn
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

CareFusion Corporation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in a peer-reviewed journal.

IPD Sharing plan:
The IPD from this trial will not be made available as the investigators do not have approval from their regional ethics committee to make this information available.

Intention to publish date

30/04/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27798020

Publication citations

Additional files

Editorial Notes

01/11/2016: Publication reference added. 20/09/2016: The IPD sharing plan has been added. 19/09/2016: The overall trial end date has been updated from 27/01/2017 to 27/01/2020. 31/05/2016: This study was submitted for registration on 19/06/2015 before the recruitment of the first participant. Following this submission, there were no subsequent changes to the information as supplied in the study record. The recruitment started on 29/07/2015, after the trialist applied for registration.