~0 spots leftby Apr 2026

The First Therapeutic Intervention in Malignant Pleural Effusion Trial

(TIME-1 Trial)

RD
Overseen byRJO Davies, Dr.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, Davis
No Placebo Group

Trial Summary

What is the purpose of this trial?

Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this. The investigators hope to find the best way to prevent pain during pleurodesis.

Research Team

RD

RJO Davies, Dr.

Principal Investigator

Oxford Pleural Unit, Churchill Hospital, Oxford, England

Eligibility Criteria

Inclusion Criteria

Histologically proven pleural malignancy OR Typical features of pleural malignancy seen on direct vision during thoracoscopy OR Pleural effusion in the context of histologically proven cancer elsewhere
Expected survival more than 1 month
Written informed consent

Treatment Details

Interventions

  • Large bore chest drain + NSAID based analgesic regimen (Procedure)
  • Large bore chest drain + opiate based analgesic regimen (Procedure)
  • Small bore chest drain + NSAID based analgesic regimen (Procedure)
  • Small bore chest drain + opiate based analgesic regimen (Procedure)
Participant Groups
4Treatment groups
Active Control
Group I: 1Active Control1 Intervention
Group II: 3Active Control1 Intervention
Group III: 4Active Control1 Intervention
Group IV: 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+
Rakesh Dixit profile image

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam profile image

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College