None listed
Conditions
Brief summary
This study will compare the costs of two routinely used skin treatments (Mepitel film and Strata XRT gel) during radiation therapy in breast cancer patients. Who is it for? You may be eligible to join this study if you are a woman aged 18 and above, have been diagnosed with breast cancer, have undergone mastectomy and are scheduled to receive radiation therapy. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have Mepitel film applied by a radiation oncology nurse before radiation therapy and reviewed at regular intervals throughout treatment period, with the film being replaced when necessary. Participants in the other group will apply Strata XRT gel themselves to the treatment area twice daily from the day of radiation therapy until two weeks after radiation therapy is completed. Cost and effectiveness of each treatment will be assessed by evaluating the cost of the skin care and the time taken by nursing staff per patient. Skin reactions will be assessed by clinicians, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and novel CPMCCW Chest Toxicity Scale. Participants will be followed-up at a minimum of once a week during treatment (minimum 5 visits), at one-week and two-weeks post-treatment, then weekly until skin reactions resolve (if applicable) and a final review 6 weeks after completion of RT. It is hoped that this information will improve current skin care practices and minimise or prevent skin reactions caused by radiation therapy.
Interventions
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 inter
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 with the patient. Intervention use will be monitored by nursing/medical staff incorporating documentation of the following assessments: * Acute Toxicity Assessment of symptoms, skin appearance and other tissues * Breast photo * Nursing staff time evaluation of skin care intervention * Skin management assessment (intervention application) Arm 2: StrataXRT StrataXRT is a flexible wound dressing routinely used for the prevention and treatment of radiation skin reactions or radiation dermatitis. It is a self-drying transparent gel that forms a protective waterproof layer which hydrates and protects skin. It is a unique formulation that requires substantially less product per application than typical moisturising creams. Radiotherapy induced skin reaction prevention and management will involve a pea-sized amount of StrataXRT gel to be applied by the patient to the area being treated with radiation twice daily, from Day 1 until 2 weeks after RT is completed. Patients are reviewed once a week, or sooner if the patient has concerns. Participants will see a Radiation Oncology Nurse on the first day of radiotherapy treatment, who will instruct patients on how to apply StrataXRT and review the expected skin changes / skin care during treatment with them. The nurse will be available to guide participants with gel application throughout treatment as much as is required. Intervention compliance will be monitored by nursing/medical staff incorporating documentation of the following assessments: * Acute Toxicity Assessment of symptoms, skin appearance and other tissues * Breast photo * Nursing staff time evaluation of skin care intervention * Skin management assessment (intervention application)
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Previous RT to the ipsilateral chest wall * Autologous breast reconstruction * Not suitable for RT to either chest wall or neo-breast as per the treating clinician
Outcome results
None listed