None listed
Conditions
Brief summary
Background Breast cancer is the most common malignancy for women in New Zealand. Radiation-induced skin reactions occur in 80-90% of breast cancer patients by completion of treatment and can severely affect patient comfort levels. We have shown that using Mepitel Film on the irradiated skin significantly decreases skin reaction severity by creating a moist healing environment and preventing friction between damaged skin and clothing or other body parts of the irradiated skin. This allows for repair of the fragile skin rather than exacerbating the damage. One of the negative aspects of Mepitel Film is that it needs to be applied very carefully by a radiation therapist or an oncology nurse once a week or more often in some patients, which takes up valuable staff resources. StrataXRT Gel is a silicone gel product that forms a thin silicone film when rubbed onto the skin, presumably with similar protective properties. Gel is applied by the patients themselves twice a day, requiring fewer hospital resources. In this RCT we want to find out if Gel is adequate compared with Film in decreasing the number of women who develop moist desquamation during or immediately after radiation for breast cancer.
Interventions
This trial will compare the effect on radiation-induced skin reactions of a new silicone product, StrataXRT. This is a silicone based gel that forms a thin transparent film once spread on the skin. The gel is thought to reduce the severity of skin reactions by protecting the irradiated skin from friction damage and create a moist wound healing environment.
StrataXRT Gel will be applied by the patient twice a day from day 1 of radiation therapy until 4 weeks after completion of treatment or unti
This trial will compare the effect on radiation-induced skin reactions of a new silicone product, StrataXRT. This is a silicone based gel that forms a thin transparent film once spread on the skin. The gel is thought to reduce the severity of skin reactions by protecting the irradiated skin from friction damage and create a moist wound healing environment. StrataXRT Gel will be applied by the patient twice a day from day 1 of radiation therapy until 4 weeks after completion of treatment or until moist desquamation occurs, whichever comes first. The amount of gel applied will be a blob the size of a thumb nail. Patients will be asked by the research radiation therapist once a week whether or not they have been compliant.
Sponsors
Molnlycke Healtcare LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed