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Vitamins also healthy after therapeutical radiation? Investigation after the effects of l-ascorbid acid and d-a-tocopherol

Vitamins also healthy after therapeutical radiation? Investigation after the effects of l-ascorbid acid and d-a-tocopherol - Vitamins also healthy after therapeutical radiation?

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34247
Enrollment
30
Registered
2011-10-11
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erytheem Roodheid

Interventions

Daily topical apply of a serum containing 15% l-ascorbic acid, 1% d-a- tocopherol and 0,1% ferulic acid

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)