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
Secondary identifying numbers N0258113080
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

Nuclear Medicine
The Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom

Phone +44 020 8661 3921
Email gcook@icr.ac.uk

Study information

Study designNon blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleSalivary gland protection from iodine-131 therapy; evaluation of salivary stimulating tablets efficacy using 131 iodine dosimetry and salivary gland scintigraphy
Study objectivesTo 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) studiedDigestive System: Salivation
InterventionRandomised test intervention versus standardised intervention, non-blinded (Phase 3).
Intervention typeOther
Primary outcome measureIf this study shows that SST has efficacy in salivary radioprotection then this could then be incorporated into standard radioiodine treatment protocols.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2002
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Nuclear Medicine
Sutton, Surrey
SM2 5PT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

The Royal Marsden NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.