Contact information
Type
Scientific
Primary contact
Dr Massimo Milani
ORCID ID
Contact details
Via A. Nota 18
Milan
20126
Italy
+39 (0)253548007
massimo.milani@mipharm.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VEF03/04
Study information
Scientific title
Acronym
VEFOAM
Study hypothesis
To evaluate if a new topical formulation of Vitamin E is efficacious in the prevention of early skin damage during radiotherapy
Ethics approval
IRB approved study protocol in April 2004
Study design
Randomised parallel group Investigator blinded
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Skin damage after radiotherapy
Intervention
Vitamin E foam topical application versus emollient standard cream
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin E foam
Primary outcome measures
1. Radiation Therapy Oncology Group (RTOG) skin score
2. Skin damage score
Secondary outcome measures
Tolerability
Overall trial start date
01/03/2004
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing radiotherapy for breast or thoracic cancer
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
Known sensibility to topical Vitamin E
Recruitment start date
01/03/2004
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Via A. Nota 18
Milan
20126
Italy
Sponsor information
Organisation
Mipharm (Italy)
Sponsor details
Via B. Quaranta 12
Milan
20126
Italy
+39 (0)253548007
massimo.milani@mipharm.it
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Mipharm SPA
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