The use of misoprostol suppositories to reduce radiotherapy-induced anorectal dysfunction
| ISRCTN | ISRCTN17865479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17865479 |
| Protocol serial number | N0263115181 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Mr R Kushwaha
Scientific
Scientific
Department of Oncology
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
| Phone | +44 (0)20 7636 8333 |
|---|---|
| r.kushwaha@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The use of misoprostol suppositories to reduce radiotherapy-induced anorectal dysfunction |
| Study objectives | What are the long-term structural and functional changes in the anorectum following pelvic radiotherapy for prostate cancer, can they be prevented by the use of misoprostol suppositories? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute radiation proctitis |
| Intervention | Randomised controlled clinical trial: 1. Misoprostol suppositories 2. Placebo |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
A reduction in acute radiation proctitis symptoms. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | 50 patients from oncology |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Middlesex Hospital
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.
