Back to resultsHydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial (HYDROSORB)
Primary Purpose
Breast Cancer, Radiation Dermatitis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Castalie water spray
Hydrogel Hydrosorb®
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Institut Curie
- Centre René Huguenin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrosorb® arm
Placebo arm
Arm Description
Hydrogel Hydrosorb®
Castalie water spray
Outcomes
Primary Outcome Measures
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
Secondary Outcome Measures
skin colorimetry measured by a colorimeter
pain level assessed by the visual analog pain scale
quality of life assessed with the Dermatology Life Quality Index questionnaire
Full Information
NCT ID
NCT02839473
First Posted
July 8, 2016
Last Updated
August 9, 2016
Sponsor
Institut Curie
Collaborators
Paul Hartmann
1. Study Identification
Unique Protocol Identification Number
NCT02839473
Brief Title
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
Acronym
HYDROSORB
Official Title
Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
Collaborators
Paul Hartmann
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiation Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrosorb® arm
Arm Type
Experimental
Arm Description
Hydrogel Hydrosorb®
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Castalie water spray
Intervention Type
Device
Intervention Name(s)
Castalie water spray
Intervention Type
Device
Intervention Name(s)
Hydrogel Hydrosorb®
Primary Outcome Measure Information:
Title
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
skin colorimetry measured by a colorimeter
Time Frame
day0, day 7, day 14, day 21, day 28
Title
pain level assessed by the visual analog pain scale
Time Frame
day0, day 7, day 14, day 21, day 28
Title
quality of life assessed with the Dermatology Life Quality Index questionnaire
Time Frame
day0, day 14, day 28
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youlia Kirova, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
We'll reach out to this number within 24 hrs