Vitamins also healthy after therapeutical radiation? Investigation after the effects of l-ascorbid acid and d-a-tocopherol
Phase 3
Completed
- Conditions
- ErytheemRoodheid10014982
- Registration Number
- NL-OMON34247
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Group sample sizes of 15 in both groups to achieve 93% power to detect a<br /><br>difference of 10,0 between the null hypothesis that both group means are 45,0<br /><br>and the alternative hypothesis that the mean of group 2 is 35,0 with estimated<br /><br>group standard deviations of 8,0 and 8,0 and with a significance level (alpha)<br /><br>of 0,05 using a two-sided two-sample t-test.</p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt</p><br>