Mepitel Film vs StrataXRT Gel in managing radiation-induced skin reactions in chest wall patients

Not Applicable

• Conditions: Breast cancer; Acute radiation-induced skin reactions; Skin - Other skin conditions; Cancer - Breast

• Registration Number: ACTRN12621000124831
• Lead Sponsor: Molnlycke Healtcare LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-08
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

All women aged 18 years and over receiving radiation for breast cancer after having had a mastectomy.

Exclusion Criteria

•Distant metastatic disease
•Previous radiation to chest area
•Skin conditions that may aggravate RT-induced reactions
•Karnofsky score <70
•Not able to come to 4 follow up sessions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the whether or not moist desquamation has developed in skin patches covered in Film and Gel using the researcher component of RISRAS (Radiation Induced Skin Reaction Assessment Scale) and the expanded RTOG (Radiation Therapy and Oncology Group) grading system.<br><br>Both RISRAS and RTOG determine the presence and extent of moist desquamation in different ways.[The primary endpoint is whether or not moist desquamation has occurred by the end of the trial.<br>This will be assessed weekly from the start of the trial, with the primary endpoint occurring at the end of the trial (4 weeks after completion of treatment).<br><br>]