Mepitel Film for the prevention of skin ulceration caused by radiation therapy in breast cancer patients.

Phase 3

Completed

• Conditions: Breast cancer patients treated with radiation; Acute side effects of radiation therapy for breast cancer; Cancer - Breast; Skin - Other skin conditions

• Registration Number: ACTRN12612000949886
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients who receive radiation therapy for breast cancer.

Exclusion Criteria

Previous radiation therapy to the chest
Metastatic disease
Inability to attend follow up sessions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moist desquamation. Moist desquamation is when the integrity of the epidermis is lost, leading to ulceration. We will use the RISRAS scale to assess all skin reactions, including moist desquamation. This Radiation-Induced Skin Reaction Assessment Scale was developed specifically for these situations by Noble Adams (Br J Nurs. 1999 Nov;8(19):1305-12) and later adjusted by McBride et al. (Cancer Nurs. 2008 Jan-Feb;31(1):E8-14).We have used this scale in our previous two trials (Diggelmann et al. BJR, 83 (2010), 971?978).[The number of skin patches in the treatment and control arms that develop moist desquamation during the trial.<br>The trial commences at the time that the patients will get their very first radiation therapy treatment. Treatment usually lasts 5 weeks. Patients will continue to be seen once a week for four weeks after completion of treatment or untill all skin reactions have been resolved.]

Secondary Outcome Measures

Name	Time	Method
Time to developing moist desquamation. Moist desquamation will be assessed under primary outcome 1.[The number of days it takes to develop moist desquamation in skin patches in the treatment and control arms after commencement of radiation treatment.];The severity of the skin reactions which will be determined by RISRAS.[RISRAS scores will be determined three times a week during treatment and once a week after completion of treatment until skin reacyions resolve (usually 4-6 weeks after treatment completion)]