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ISRCTN
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ISRCTN67519330
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ClinicalTrials.gov identifier
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Public title
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Randomised double-blind placebo controlled study to determine whether the use of selective digestive decontamination pastilles reduces radiation mucositis
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Scientific title
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Acronym
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N/A
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Serial number at source
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HN9
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double-blind placebo controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Head and neck
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Participants - inclusion criteria
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1. Patients with head and neck cancer receiving potentially curative doses of radiotherapy
2. Eligible patients may have squamous carcinoma, adenocarcinoma or salivary tumours arising in the oral cavity, nas -oro, or hypopharynx, larynx and paranasal sinuses
3. Stages T1-T4
4. No allergy to Polymyxin E, Tobramycin or Amphotericin B
5. No pre-existing oral or oropharyngeal infection
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1999
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Anticipated end date
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31/12/2000
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Group A: Active SSD pastille (Polymyxin E 2 mg, Tobramycin 1.8 mg and Amphotericin B 10 mg). Treatment to start on the day radiotherapy begins, one pastille four times daily until radiation reactions have settled.
2. Group B: Placebo pastille four times daily. Treatment to start on the first day of radiotherapy until radiation reactions have settled.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Not available
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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unknown@sponsor.com
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Date applied
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01/07/2001
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Last edited
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13/05/2008
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Date ISRCTN assigned
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01/07/2001
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