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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15503522

Enrollment

142

Registered

2015-09-30

Start date

2015-07-29

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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 Guidel

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026