Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Helen Spickett
ORCID ID
Contact details
Rosemere Cancer Centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
-
helen.spickett@lsccn.nhs.uk
Additional identifiers
EudraCT number
2006-002352-15
ClinicalTrials.gov number
Protocol/serial number
2191
Study information
Scientific title
A randomised, double-blind controlled trial of mometosone furoate cream versus placebo to prevent radiation dermatitis of the breast and chest wall
Acronym
Skin Study
Study hypothesis
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.
Ethics approval
MREC approved (ref: 06/Q0201/79)
Study design
Single centre randomised interventional process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention
Placebo or mometasone furoate. Assessments are taken at baseline, day 8, 15, 21, 29, 36 and 43.
Study entry: single randomisation only
Intervention type
Drug
Phase
Phase III
Drug names
Mometasone furoate
Primary outcome measures
Change in visual skin assessment
Secondary outcome measures
1. Objective skin assessment
2. Changes in quality of life measures
Overall trial start date
02/11/2009
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
1. Skin involvement of disease
2. Untreated bacterial, fungal or viral skin lesions
3. Inability to self administer creams
Recruitment start date
02/11/2009
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rosemere Cancer Centre
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
Lancashire Teaching Hospitals NHS Trust (UK)
Sponsor details
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Rosemere Cancer Foundation (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