Efficacy of a new Vitamin E foam in prevention of early skin damage in patients undergoing radiotherapy

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Massimo Milani
Scientific

Via A. Nota 18
Milan
20126
Italy

Phone	+39 (0)253548007
Email	massimo.milani@mipharm.it

Primary study design	Interventional
Study design	Randomised parallel group Investigator blinded
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	VEFOAM
Study objectives	To evaluate if a new topical formulation of Vitamin E is efficacious in the prevention of early skin damage during radiotherapy
Ethics approval(s)	IRB approved study protocol in April 2004
Health condition(s) or problem(s) studied	Skin damage after radiotherapy
Intervention	Vitamin E foam topical application versus emollient standard cream
Intervention type	Supplement
Primary outcome measure(s)	1. Radiation Therapy Oncology Group (RTOG) skin score 2. Skin damage score
Key secondary outcome measure(s)	Tolerability
Completion date	01/06/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key inclusion criteria	Patients undergoing radiotherapy for breast or thoracic cancer
Key exclusion criteria	Known sensibility to topical Vitamin E
Date of first enrolment	01/03/2004
Date of final enrolment	01/06/2005

Via A. Nota 18

Milan
20126
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan