The most important objective from this investigation is to prevent or substitute the damage which is coused by therapeutical radiation. As it's most likely that the skin damage as a result of therapeutical radiation can be more limited. From…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Group sample sizes of 15 in both groups to achieve 93% power to detect a
difference of 10,0 between the null hypothesis that both group means are 45,0
and the alternative hypothesis that the mean of group 2 is 35,0 with estimated
group standard deviations of 8,0 and 8,0 and with a significance level (alpha)
of 0,05 using a two-sided two-sample t-test.
Secondary outcome
nvt
Background summary
Making a start with the development of a scientific guidline for the treament
of the skin after therapeutical radiation
Study objective
The most important objective from this investigation is to prevent or
substitute the damage which is coused by therapeutical radiation. As it's most
likely that the skin damage as a result of therapeutical radiation can be more
limited.
From former studies is shown that the effects of l-ascorbic acid and d-α-
tocopherol are exceptional in comparing to other products. Recently there has
been a literary studie where former studies haven been put together, this is
shown in addendement C from the protocol.
l-Ascorbic acid and d-α-tocopherol are able to reduce free radicals, whereby
the skin is able to recoverand to protect itself.
The investigations after the effects of l-ascorbic acid and d-α-tocopherol are
tested, only after ultraviolet radiation. Thereby is there in this
investigation searched if both ultraviolet as ionizing radiation cause similar
damage, there has been found clear similarities.
Study design
A pilotstudy where the choise has been made to treat half of the patients with
and the other half without the use of the serum
Intervention
Daily topical apply of a serum containing 15% l-ascorbic acid, 1% d-α-
tocopherol and 0,1% ferulic acid
Study burden and risks
The patients will be minimal loaded as the measurments will be directly after
their therapeutical radiation. Where will als be the oppurtunity to fill in the
questionarys.
At home the patients will be applying the serum topical at the breast. This
will only take seconds.
Futher there is no load and the risks are very low, there can only be developed
a hypersensitivity for one of the ingredients and in the most unlikely case the
treatment will be less effective.
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Listed location countries
Age
Inclusion criteria
1.Woman diagnosed with breastcancer which have undergone breast saving therapie
2.Radiation according to the "new" method from 21 treatments.
3.WHO-performace status 0-2
4.Skintyp according to Fitzgerald 1-4
5.Gave their permission
Exclusion criteria
1.Patientgroup shouldn't be treated or being treated with chemotherapy
2.No radiotherpy in the past
3.No hypertrofia / keloidal scarring
4.No metastases
5.No diabetes mellitus type 1&2
6.No illness which can influence the skinrecovery
7.No medication which couse hypersensibility from the skin
8.No hypersensitivity for one of the ingredients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020864-39-NL |
| CCMO | NL33434.044.10 |
| Other | Volgt z.s.m. |