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

Institut Curie

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Radiation Dermatitis

Treatments: Device: Castalie water spray; Device: Hydrogel Hydrosorb®

Study type: Interventional

Funder types: Other

Identifiers

NCT02839473

IC 2009-07

Details and patient eligibility

About

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.

Enrollment: 278 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups, including a placebo group

Hydrosorb® arm

Experimental group

Description:

Hydrogel Hydrosorb®

Treatment:

Device: Hydrogel Hydrosorb®

Placebo arm

Placebo Comparator group

Description:

Castalie water spray

Treatment:

Device: Castalie water spray