NCT00896285

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

5.7 years

First QC Date

May 7, 2009

Last Update Submit

July 16, 2015

Conditions

Malignant Pleural EffusionPleural Effusion

Keywords

Pleural malignancypleural effusionpleurodesischest tubecancercancer pain management

Outcome Measures

Primary Outcomes (2)

  • An average pain score over 72 hours post pleurodesis for malignant pleural effusion

    72 hours

  • Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)

    3 months

Secondary Outcomes (2)

  • Presence of chronic chest pain on the side of the pleurodesis

    6 weeks

  • Presence of chronic chest pain on the side of the pleurodesis

    6 months

Study Arms (4)

1

ACTIVE COMPARATOR
Other: Large bore chest drain + NSAID based analgesic regimen

2

ACTIVE COMPARATOR
Other: Small bore chest drain + NSAID based analgesic regimen

3

ACTIVE COMPARATOR
Other: Large bore chest drain + opiate based analgesic regimen

4

ACTIVE COMPARATOR
Other: Small bore chest drain + opiate based analgesic regimen

Interventions

Large bore chest drain + NSAID based analgesic regimenOTHER

Chest tube greater than 14 French size and ibuprofen.

1
Small bore chest drain + NSAID based analgesic regimenOTHER

Chest tube less than or equal to 14 French size and ibuprofen.

2
Large bore chest drain + opiate based analgesic regimenOTHER

Chest tube greater than 14 French size and morphine.

3
Small bore chest drain + opiate based analgesic regimenOTHER

Chest tube less than or equal to 14 French size and morphine.

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
  • 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

You may not qualify if:

  • Age \< 18 years
  • Primary lymphoma or small cell lung carcinoma
  • Patients who are pregnant or lactating
  • Inability to give informed consent
  • History of GI bleeding or of untreated peptic ulceration
  • Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen
  • Hypercapnic respiratory failure
  • Known intravenous drug abuse
  • Severe renal or liver disease
  • Known bleeding diathesis
  • Warfarin therapy
  • Current or recent (within 2 weeks) corticosteroid steroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Pleural Effusion, MalignantPleural EffusionNeoplasms

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural DiseasesRespiratory Tract Diseases

Study Officials

  • RJO Davies, Dr.

    Oxford Pleural Unit, Churchill Hospital, Oxford, England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 11, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

US(1)