None listed
Conditions
Brief summary
This study aims to compare the efficacy of two different creams for the management of radiation-induced skin reactions in patients with cancer. Who is it for? You may be eligible to join this study if you are aged over 18 and are scheduled to undergo radical radiotherapy for lung cancer, breast cancer or head and neck cancer at the Royal Brisbane and Women’s Hospital. You will not be eligible if you have any pre-existing skin conditions or have any known allergies towards any ingredient of either of the creams. Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will apply a natural oil-based emulsion containing allantoin to their skin twice a day or more as needed depending on the occurrence of radiation-induced skin reactions. Participants in the other group will use an aqueous (water-based) cream instead. Participants will not know which cream they are using until the end of the trial. Participants will be assessed prior to radiotherapy, weekly during radiotherapy, and four weeks after the completion of radiotherapy, in order to determine the effects of both creams in reducing radiation-induced skin reactions, improving pain, itching and quality of life.
Interventions
A natural oil-based emulsion containing allantoin
A natural oil-based emulsion, as known as Moogoo Udder Cream (Registered Trademark), is a Queensland owned product that comprises allantoin, purified water, sweet almond oil, olive oil, rice bran oil, emulsifying wax, milk protein, aloe vera, vitamin E, glycerol caprylate, piroctone alamine and guarsilk.
Patients will be asked to start topical application of their allocated cream on the area of skin being irradiated at the onset of radiotherap
A natural oil-based emulsion containing allantoin A natural oil-based emulsion, as known as Moogoo Udder Cream (Registered Trademark), is a Queensland owned product that comprises allantoin, purified water, sweet almond oil, olive oil, rice bran oil, emulsifying wax, milk protein, aloe vera, vitamin E, glycerol caprylate, piroctone alamine and guarsilk. Patients will be asked to start topical application of their allocated cream on the area of skin being irradiated at the onset of radiotherapy, twice a day or more as needed depending on the occurrence of RISR and pain, until the skin reaction subsides. The amount of cream dispensed to each patient will be recorded throughout treatment. If moist desquamation occurs, the topical preparation will be discontinued in the area of skin breakdown and dressings will be applied until the wound heals as per standard care. Patients will be asked to still continue with the topical preparation onto irradiated area that has no breakdown. All participants are given written instructions on how to apply the allocated treatment.
Sponsors
Raymond Chan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Participants in this study will all be patients receiving radical radiotherapy for lung cancer, breast cancer and head and neck cancer at the Royal Brisbane and Women’s Hospital . A sample of consecutive eligible and consented patients will be recruited into the study. 1. Age >18 years 2. Patients who have a definitive diagnosis of breast cancer, lung cancer or head and neck cancer 3. Patients who are receiving radiotherapy (>50 Gy) either as primary treatment or postoperative treatment to their chest, breast or head and neck.
Exclusion criteria
1. Patients who are unable to consent 2. Patients with pre-existing skin rash, ulceration or open wound in the treatment area 3. Patients with known allergic and other systemic skin diseases even not directly affecting irradiated fields. 4. Patients with any known allergic reactions towards any ingredient of either the Moogoo Udder Cream (Registered Trademark) or the aqueous cream and failed the patch test.
Outcome results
None listed