None listed
Conditions
Brief summary
TThis study is being conducted to assess a new skin product against the standard skin care procedures at Townsville Cancer Center (TCC) in breast cancer patients receiving external beam radiation therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have a confirmed diagnosis of breast cancer, for which you will be undergoing external beam radiation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the current standard skin care management. That is, an aqueous cream, Sorbolene, applied daily after radiation therapy treatment. Participants in the other group will instead receive a new product called StrataXRT, which is a silicone based gel applied to the skin which acts as a barrier to prevent the development of radiation-induced skin reactions. The product is TGA approved in Australia; FDA approved in the United States and is being used clinically in other centres in Australia. All participants will be assessed at the beginning of treatment and weekly thereafter using a specific skin grading scale, and clinical photographs will be taken. The study is attempting to determine if StrataXRT is equivalent to current practices, and whether further study on the product is warranted.
Interventions
This study aims to examine the use of StrataXRT silicone gel in the management and prophylaxis of skin reactions on patients receiving external beam radiation therapy to the whole breast at Townsville Cancer Center (TCC). StrataXRT is Therapeutic Goods Administration approved product in Australia. The silcone-based gel has two aims: prophylatic care of skin to reduce skin reactions and improve skin care management once a reaction occurs. The outcomes from this pilot will also help investigator
This study aims to examine the use of StrataXRT silicone gel in the management and prophylaxis of skin reactions on patients receiving external beam radiation therapy to the whole breast at Townsville Cancer Center (TCC). StrataXRT is Therapeutic Goods Administration approved product in Australia. The silcone-based gel has two aims: prophylatic care of skin to reduce skin reactions and improve skin care management once a reaction occurs. The outcomes from this pilot will also help investigators determine if further study is warranted. A 20 gram tube of StrataXRT will be provided to the patient. Stratpharma, the pharmaceutical company representing StrataXRT, have indicated that one tube should be sufficient for the entire length of treatment, with one application per day for five weeks of treatment with enough product left over for post-treatment application. Additional StrataXRT gel will be provided if required. The first application of StrataXRT will be on the patient’s first day of treatment and will be done by the investigating radiation therapists as recommended by Stratpharma. This will continue for the first week of treatment and ensures the correct amount (approximately the size of a 5 cent coin) is applied. The gel should form a thin, clear barrier if applied properly. During this time, patients will be instructed on the correct application of the product by one of the two investigating therapists. This will facilitate correct application by the individual patient for the remainder of treatment. Patients should continue to use their allocated product until the skin reaction has resolved. In patients where moist desquamation develops, StrataXRT will continue to be used for skin care. Patients using Sorbolene cream will see nursing staff for appropriate management or dressings Adherence to the product will be queried at weekly review. As with current standard skin care, self-reporting adherence is the only monitor of compliance. If patients are unable to comply with skin care product application, they will taken off the trial.
Sponsors
The Townsville Hospital
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
Inclusion Criteria: * Patients need to be receiving/ or scheduled to receive external beam radiation therapy in order to be eligible. * Early or Local staged breast cancer * Aged 18 years or older * Histological or cytologically confirmed Breast cancer * Patients with a whole intact breast * An ECOG performance status score of 1 or less * Has provided written Informed Consent for participation in this trial * Treatment in the supine position
Exclusion criteria
Exclusion Criteria: * Evidence of distant metastases * Already exposed to ionising radiation in the affected area * Any patients requiring bolus * Dose constraints to critical structures are not achieved * Pregnant women and human foetus * Under 18 years of age * Unable to consent * Any cognitive or mental impairment that could prevent compliance to the required protocol * Any patients who deviate from standard protocol
Outcome results
None listed