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
| ISRCTN | ISRCTN35591640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35591640 |
| Secondary identifying numbers | N0436099009 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Henry
Scientific
Scientific
Department of Respiratory Medicine
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Randomised three-arm active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | To compare the efficacy of these three agents in preventing recurrence of malignant pleural effusion in a randomised controlled trial setting. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Malignant pleural effusion |
| Intervention | Randomised controlled trial. Random allocation to: 1. Sterile talc 2. Tetracycline 3. Bleomycin |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/06/2001 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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.) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/12/2015: no publications found on PubMed.
