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
Scientific
Via A. Nota 18
Milan
20126
Italy
| Phone | +39 (0)253548007 |
|---|---|
| massimo.milani@mipharm.it |
Study information
| Study design | Randomised parallel group Investigator blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | 1. Radiation Therapy Oncology Group (RTOG) skin score 2. Skin damage score |
| Secondary outcome measures | Tolerability |
| Overall study start date | 01/03/2004 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via A. Nota 18
Milan
20126
Italy
20126
Italy
Sponsor information
Mipharm (Italy)
Industry
Industry
Via B. Quaranta 12
Milan
20126
Italy
| Phone | +39 (0)253548007 |
|---|---|
| massimo.milani@mipharm.it | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
