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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrosorb® arm

Hydrogel Hydrosorb®

Group Type EXPERIMENTAL

Hydrogel Hydrosorb®

Intervention Type DEVICE

Placebo arm

Castalie water spray

Group Type PLACEBO_COMPARATOR

Castalie water spray

Intervention Type DEVICE

Interventions

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Castalie water spray

Intervention Type DEVICE

Hydrogel Hydrosorb®

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No