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

Phase 3

Completed

• Conditions: Radiation Dermatitis; Breast Cancer
• Interventions: Device: Hydrogel Hydrosorb®; Device: Castalie water spray

• Registration Number: NCT02839473
• Lead Sponsor: Institut Curie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 278

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrosorb® arm	Hydrogel Hydrosorb®	Hydrogel Hydrosorb®
Placebo arm	Castalie water spray	Castalie water spray

Primary Outcome Measures

Name	Time	Method
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.	through study completion, an average of 3 years

Secondary Outcome Measures

Name	Time	Method
quality of life assessed with the Dermatology Life Quality Index questionnaire	day0, day 14, day 28
skin colorimetry measured by a colorimeter	day0, day 7, day 14, day 21, day 28
pain level assessed by the visual analog pain scale	day0, day 7, day 14, day 21, day 28

Trial Locations

Locations (2)

Institut Curie; 🇫🇷 Paris, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France