CompletedPhase 3

Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

France278 participantsStarted 2010-03

Plain-language summary

The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women treated by normo fractionated radiotherapy for breast cancer * Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study. Exclusion criteria: * Were male patients * Radiation dermatitis already treated or caused by another treatment * Subjects deprived of their freedom or under guardianship * Subjects in whom medical follow-up was impossible * A cancer wound or skin flap on the irradiated zone * A history of allergic skin reaction * Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.

What they're measuring

local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.

Timeframe: through study completion, an average of 3 years

Trial details

NCT IDNCT02839473

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

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