Salivary gland protection from iodine-131 therapy; evaluation of salivary stimulating tablets efficacy using 131 iodine dosimetry and salivary gland scintigraphy
| ISRCTN | ISRCTN88337776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88337776 |
| Protocol serial number | N0258113080 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Marsden NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/09/2016
- 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
Dr Gary Cook
Scientific
Scientific
Nuclear Medicine
The Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
| Phone | +44 020 8661 3921 |
|---|---|
| gcook@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Salivary gland protection from iodine-131 therapy; evaluation of salivary stimulating tablets efficacy using 131 iodine dosimetry and salivary gland scintigraphy |
| Study objectives | To compare iodine-131 salivary gland dosimetry in patients taking SST and those under a standard treatment protocol (sucking sweets). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Salivation |
| Intervention | Randomised test intervention versus standardised intervention, non-blinded (Phase 3). |
| Intervention type | Other |
| Primary outcome measure(s) |
If this study shows that SST has efficacy in salivary radioprotection then this could then be incorporated into standard radioiodine treatment protocols. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nuclear Medicine
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
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
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.
