Condition category
Cancer
Date applied
08/11/2005
Date assigned
10/11/2005
Last edited
10/11/2005
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes