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ISRCTN
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ISRCTN03885092
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ClinicalTrials.gov identifier
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Public title
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A randomised, double-blind controlled trial of mometosone furoate cream versus placebo to prevent radiation dermatitis of the breast and chest wall
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Scientific title
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Acronym
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Skin Study
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Serial number at source
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2191
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Study hypothesis
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A prospective, double blind, randomised study investigating the effect of mometasone furoate on the prevention of radiation dermatitis of the breast and chest wall. Scoring systems include visual scoring and reflectance spectrometry. Participants receiving a 40 Gy, 15 fractionated, 3 week radical course of whole breast radiotherapy plus or minus breast boost will be eligible.
As of 17/02/2011 the anticipated end date for this trial has been updated from 01/01/2010 to 31/07/2011.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-effect-using-steroid-cream-decrease-skin-reactions-caused-having-radiotherapy
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Ethics approval
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MREC approved (ref: 06/Q0201/79)
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Study design
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Single centre randomised interventional process of care trial
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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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Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
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Participants - inclusion criteria
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1. Aged 18 years or over, either sex
2. Receiving 40 Gy 15 fractionated, 3 week radical radiotherapy to the breast or chest wall
3. Patient provides informed consent to participate in the study and completes follow up
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Participants - exclusion criteria
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1. Skin involvement of disease
2. Untreated bacterial, fungal or viral skin lesions
3. Inability to self administer creams
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Anticipated start date
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02/11/2009
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Anticipated end date
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31/07/2011
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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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Planned sample size: 120; UK sample size: 120
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Interventions
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Placebo or mometasone furoate. Assessments are taken at baseline, day 8, 15, 21, 29, 36 and 43.
Study entry: single randomisation only
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Primary outcome measure(s)
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Change in visual skin assessment
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Secondary outcome measure(s)
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1. Objective skin assessment
2. Changes in quality of life measures
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Sources of funding
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Rosemere Cancer Foundation (UK)
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Trial website
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Publications
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Contact name
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Ms
Helen
Spickett
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Address
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Rosemere Cancer Centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
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City/town
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Preston
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Zip/Postcode
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PR2 9HT
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Country
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United Kingdom
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Email
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helen.spickett@lsccn.nhs.uk
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Sponsor
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Lancashire Teaching Hospitals NHS Trust (UK)
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Address
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Royal Preston Hospital
Sharoe Green Lane
Fulwood
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City/town
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Preston
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Zip/Postcode
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PR2 9HT
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Country
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United Kingdom
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Sponsor website:
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http://www.lancsteachinghospitals.nhs.uk/
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Date applied
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07/07/2010
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Last edited
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28/06/2011
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Date ISRCTN assigned
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07/07/2010
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