Contact information
Type
Scientific
Primary contact
Dr Gary Cook
ORCID ID
Contact details
Nuclear Medicine
The Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 020 8661 3921
gcook@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258113080
Study information
Scientific title
Salivary gland protection from iodine-131 therapy; evaluation of salivary stimulating tablets efficacy using 131 iodine dosimetry and salivary gland scintigraphy
Acronym
Study hypothesis
To compare iodine-131 salivary gland dosimetry in patients taking SST and those under a standard treatment protocol (sucking sweets).
Ethics approval
Not provided at time of registration
Study design
Non blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Digestive System: Salivation
Intervention
Randomised test intervention versus standardised intervention, non-blinded (Phase 3).
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
If this study shows that SST has efficacy in salivary radioprotection then this could then be incorporated into standard radioiodine treatment protocols.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2002
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuclear Medicine
Sutton, Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden 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