Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Henry

ORCID ID

Contact details

Department of Respiratory Medicine
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436099009

Study information

Scientific title

A study to compare the efficiency of sterile talc, tetracycline and bleomycin as sclerosing agents for medical pleurodesis in the treatment of malignant pleural effusions

Acronym

Study hypothesis

To compare the efficacy of these three agents in preventing recurrence of malignant pleural effusion in a randomised controlled trial setting.

Ethics approval

Not provided at time of registration

Study design

Randomised three-arm active-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malignant pleural effusion

Intervention

Randomised controlled trial. Random allocation to:
1. Sterile talc
2. Tetracycline
3. Bleomycin

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

This study should provide information as to which of these most commonly used agents for medical pleurodesis is most effective in preventing further malignant pleural effusions. It should provide information on which agent if any is associated with more prolonged survival. It should provide information on issues such as pain and infection rates during pleurodesis with these agents. Hopefully, these data will lead to an evidence based choice of sclerosing agent for cancer patients with malignant pleural effusions.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Predominantly lung cancer patients with a selection of other cancer patients with malignancy effusions. (This is likely to be mostly breast cancer patients.)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2001

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/12/2015: no publications found on PubMed.