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

Breast Cancer Clinical Trial

— HYDROSORB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839473
• Other study ID #: IC 2009-07
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: July 2014

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Device:
• Castalie water spray

• Hydrogel Hydrosorb®

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Centre René Huguenin	Saint Cloud

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	Paul Hartmann

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	skin colorimetry measured by a colorimeter		day0, day 7, day 14, day 21, day 28
Secondary	pain level assessed by the visual analog pain scale		day0, day 7, day 14, day 21, day 28
Secondary	quality of life assessed with the Dermatology Life Quality Index questionnaire		day0, day 14, day 28