None listed
Conditions
Brief summary
The primary purpose of this trial is to investigate the efficacy of StrataXRT in reducing the incidence and rate of onset of radiation dermatitis in head and neck cancer patients undergoing radiotherapy. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with a head or neck cancer for which you are receiving radiotherapy (>50Gy) with or without concurrent chemotherapy or biotherapy. Study details Participants enrolled in this trial will be randomly allocated (by chance) to receive either StrataXRT gel or 10% Glycerine (Sorbolene). The allocated dressing will be applied to the irradiated skin, twice a day until the skin reaction subsides, up to 4 weeks post treatment. Participants will complete a range of questionnaires by interview every week from the start of radiotherapy and four weeks following the completion of radiotherapy, in addition to collecting data on radiation dermatitis symptoms, healthcare costs and side effects. It is hoped that results from this trial will provide information on whether StrataXRT is more safe and effective than Sorbolene for the prevention and treatment of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.
Interventions
StrataXRT 'Registered Trademark' is a TGA-approved silicon-based topical preparation, consisting of polydimethylsiloxanes, Siloxanes, and Alkylmethyl Silicones
Patients will be asked to start topical application of their allocated topical preparation on the area of skin being irradiated at the onset of radiotherapy, twice a day until the skin reaction subsides, up to 4 weeks post treatment. The amount of topical preparation dispensed to each patient will be recorded throughout treatment. If moi
StrataXRT 'Registered Trademark' is a TGA-approved silicon-based topical preparation, consisting of polydimethylsiloxanes, Siloxanes, and Alkylmethyl Silicones Patients will be asked to start topical application of their allocated topical preparation on the area of skin being irradiated at the onset of radiotherapy, twice a day until the skin reaction subsides, up to 4 weeks post treatment. The amount of topical preparation dispensed to each patient will be recorded throughout treatment. If moist desquamation occurs, Group one will continue to apply StrataXRT 'Registered Trademark' in addition to Atrauman 'Registered Trademark' dressing and non-sterile combine roll until the wound heals as per standard practice. Patients will be asked to still continue with the allocated topical preparation onto irradiated areas that have no skin breakdown. All participants will be given written instructions on how to apply the allocated treatment.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants in this study will be patients receiving radical radiotherapy +/- concurrent chemotherapy or biotherapy for head and neck cancer at the Royal Brisbane and Women's Hospital *Age >18 years *Patients who have a definitive diagnosis of head and neck cancer *Patients who are receiving radiotherapy (>50 Gy) either as primary treatment or postoperative treatment to their head and neck.
Exclusion criteria
*Patients who are unable to consent *Patients with pre-existing skin rash, ulceration or open wound in the treatment area *Patients with known allergic and other systemic skin diseases even not directly affecting irradiated fields. *Patients with any known allergic reactions towards any ingredient of either the StrataXRT 'Registered Trademark' or the Sorbolene and failed the patch test.
Outcome results
None listed