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

ISRCTN ISRCTN28188789
DOI https://doi.org/10.1186/ISRCTN28188789
Secondary identifying numbers VEF03/04
Submission date
08/11/2005
Registration date
10/11/2005
Last edited
10/11/2005
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

Dr Massimo Milani
Scientific

Via A. Nota 18
Milan
20126
Italy

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

Study information

Study designRandomised parallel group Investigator blinded
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymVEFOAM
Study objectivesTo 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) studiedSkin damage after radiotherapy
InterventionVitamin E foam topical application versus emollient standard cream
Intervention typeSupplement
Primary outcome measure1. Radiation Therapy Oncology Group (RTOG) skin score
2. Skin damage score
Secondary outcome measuresTolerability
Overall study start date01/03/2004
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80
Key inclusion criteriaPatients undergoing radiotherapy for breast or thoracic cancer
Key exclusion criteriaKnown sensibility to topical Vitamin E
Date of first enrolment01/03/2004
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • Italy

Study participating centre

Via A. Nota 18
Milan
20126
Italy

Sponsor information

Mipharm (Italy)
Industry

Via B. Quaranta 12
Milan
20126
Italy

Phone +39 (0)253548007
Email massimo.milani@mipharm.it
ROR logo "ROR" https://ror.org/0441v1872

Funders

Funder type

Industry

Mipharm SPA

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan