A trial looking at quality of life in the treatment of patients with malignant pleural effusion

ISRCTN	ISRCTN15503522
DOI	https://doi.org/10.1186/ISRCTN15503522
Secondary identifying numbers	CPMS 19615

Submission date: 30/09/2015
Registration date: 30/09/2015
Last edited: 24/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-2-ways-to-treat-a-build-up-of-fluid-around-the-lung-optimum#undefined

Contact information

Dr Parthipan Sivakumar
Scientific

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

ORCID ID	0000-0003-3740-2612

Dr Liju Ahmed
Scientific

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

ORCID ID	0000-0001-7722-8829
Phone	+44 (0)20 7188 7188
Email	liju.ahmed@gstt.nhs.uk

Study information

Study design	Single-centre randomized parallel trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	OPTIMUM
Study objectives	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(s)	First Medical Research Ethics Committee, 22/06/2015, ref: 15/LO/1018
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	29/07/2015
Completion date	27/01/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 142; UK Sample Size: 142
Total final enrolment	142
Key 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
Key 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.
Date of first enrolment	29/07/2015
Date of final enrolment	27/10/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Thomas's Hospital

249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Guy's & St Thomas' NHS Foundation Trust
Hospital/treatment centre

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

"ROR"	https://ror.org/00j161312

Funders

Funder type

Industry

CareFusion Corporation

No information available

Results and Publications

Intention to publish date	31/12/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/10/2016		Yes	No
HRA research summary			28/06/2023	No	No
Results article		23/11/2023	24/11/2023	Yes	No

Editorial Notes

24/11/2023: Publication reference and total final enrolment added.
15/11/2023: The intention to publish date has been changed from 01/06/2022 to 31/12/2023.
02/03/2022: The intention to publish date has been changed from 30/04/2017 to 01/06/2022.
08/08/2019: Internal review.
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.