A comparison of two routinely used skin treatments for women with breast cancer undergoing radiation therapy

INTERVENTION: In many cases following mastectomy, women require post‐mastectomy radiation therapy (PMRT). Radiation skin reactions (or radiation dermatitis) are common and expected side effects of radiation treatment. Radiotherapy (RT) centres routinely implement skin care management systems applied to patients receiving breast cancer radiotherapy with the aim of preventing or minimising radiation skin reactions. This project is a randomised evaluation study comparing two routinely used skin management interventions (Mepitel Film + Strata XRT gel); aiming to assess the difference in cost‐benefit and effectiveness. Post‐mastectomy Radiation Therapy (PMRT): Standard radiation treatment will be delivered in both intervention arms. The conventional dose of 50 Gray (Gy) at 2.0 Gy per fraction over 25 fractions will be used; daily fractionation will be delivered Monday ‐ Friday, with 9‐10 fractions delivered per fortnight. Participants will be randomised to one of two treatments arms prior to the commencement of PMRT. Arm 1: Mepitel Film Mepitel Film is a protective film dressing. It protects fragile skin allowing it to heal undisturbed. It is applied onto the skin while patients are in the same position required for the delivery of radiation treatment. Radiotherapy induced skin reaction prevention and management will involve the placement of Mepitel film onto skin in the radiation treatment fields, by Radiation Oncology Nursing Staff from Day 1 until 2 weeks after RT is completed. Mepitel Film is first applied on day one of RT, then reviewed at regular intervals though treatment, or sooner if the patient has concerns. The thin film may need to be replaced several times. Mepitel film will be applied in Radiation Therapy treatment facilities. Participants will see a Radiation Oncology Nurse on the first day of radiotherapy treatment who will explain Mepitel Film application and review the expected skin changes / skin care during treatment w CONDITION: Breast Cancer;Acute radiation therapy (RT) skin toxicity and management; ; Breast Cancer ; Acute radiation therapy (RT) skin toxicity and management Cancer ‐ Breast Skin ‐ Other skin conditions SECONDARY OUTCOME: Acute PMRT skin toxicity ; ; A trial‐specific paper flow‐sheet will be completed by clinicians documenting skin toxicity during and after treatment; according to: ; * The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 ; * Novel Chest Toxicity Scale for Women with Breast Cancer ; * Chest photograph[*Pre radiotherapy ; * A minimum of weekly during PMRT ; * Post PMRT (week 1 and week 2) ; * Weekly until side effects resolved where applicable ; * Week 6 post‐PMRT] Rates of other acute PMRT toxicity ; ; A trial‐specific paper flow‐sheet will be completed by clinicians documenting skin toxicity during and after treatment; according to: ; * The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0[*Pre radiotherapy ; * A minimum of weekly during PMRT ; * post PMRT (week 1 and week 2) ; * where applicable weekly until side effects resolved ; * week 6 post‐PMRT.] INCLUSION CRITERIA: * Women aged greater than or equal to 18 years old * Breast cancer diagnosis * Patient has undergone mastectomy * Require RT to either chest wall or neo‐breast; (temporary expander or implant in situ following mastectomy). * Bolus must be used with RT * Available for follow‐up on a weekly basis (minimum) during RT, for two weeks after RT, then until resolution of moist desquamation; and at 6 weeks after RT PRIMARY OUTCOME: Difference in the cost of resources used (application of treatment for acute PMRT toxicity prevention and treatment, dressings and nursing time).; ; Health care professionals – time: ; Time will be recorded in minutes for the direct care given to the skin, including the application of Mepitel dressings, StrataXRT or management of moist desquamation.; ; Costs ‐ consumables required for skin care, minimisation and management of acute skin toxicity; * Each day the patient is reviewed, items involved with the above will be tallied; * The list of these items to be recorded include but are not limited to gloves, dressings, creams, StrataXRT, Mepitel dressings; * The specific costs in AUD, will be calculated centrally by the research team after data are entered into the ECRF:; ; A trial‐specific paper flow‐sheet will be provided to sites for the documentation of resource use/time during and after treatment. ; ; [*Pre radiotherapy; * A minimum of weekly during PMRT; * post PMRT (week 1 and week 2); * where applicable weekly until side effects resolved; * week 6 post‐PMRT.]