StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12619001477112
• Lead Sponsor: Genesis Cancer Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-30
• Study Start: 2019-10-25
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

Histologically confirmed breast cancer.
Recent mastectomy.
Suitable for post-mastectomy chest wall and nodal radiotherapy.
Able and willing to comply with daily treatments and weekly assessments up to 10 weeks from commencement of radiotherapy
Age at least 18 years.
Has given written informed consent.

Exclusion Criteria

Contraindication to radiotherapy, eg ataxia, telangiectasia.
Prior radiotherapy to the breast
Skin which is unsuitable for application of Mepitel Film or StrataXRT.
Not medically competent to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time-weighted average grade of dermatitis will be calculated by multiplying the number of days between consecutive assessments by the average grade of the two assessments bounding each interval. The sum over all intervals will be divided by the total number of days from commencing radiotherapy to the last assessment or 10 weeks, whichever is earlier. If the patient ceases assessments before 10 weeks and the grades on the last assessment are 0, the grades will be assumed to be 0 for the rest of the time up to 10 weeks.[ 10 weeks from commencement of radiotherapy]

Secondary Outcome Measures

Name	Time	Method
Worst grade of radiation-induced dermatitis within 10 weeks- patient reported and clinical assesment<br><br>[10 weeks from start of radiation treatment- <br>assessment will be weekly];Occurrence of moist desquamation- patient reported and clinical assesment[10 weeks from start of radiation treatment- <br>assessment will be weekly];Patient preference for either product- patient reported [10 weeks from start of radiation treatment- <br>assessment will be weekly];Feasibility and compliance with applications of both products(composite secondary)- patient reported and clinical assessment[10 weeks from start of radiation treatment- <br>assessment will be weekly]