RecruitingPhase 3ACTRN12612000568819

A double-blind randomised controlled trial of a natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer

The effectiveness of a natural oil-based emulsion containing allantoin versus aqueous cream for improving the outcomes associated with radiation-induced skin reactions in patients with cancer

Sponsor

Raymond Chan

Enrollment

172 participants

Start Date

Oct 15, 2012

Study Type

Interventional

Conditions

Radiation-induced skin reactions in patients with cancer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 99 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two creams for managing skin reactions caused by radiation therapy in people with lung, breast, or head and neck cancer. Radiation commonly causes the skin in the treated area to become red, sore, and irritated — similar to a severe sunburn. One cream is a natural oil-based emulsion containing allantoin, and the other is a standard aqueous (water-based) cream. Participants will not know which cream they receive until the study ends. You may be eligible if: - You are 18 years of age or older - You have a confirmed diagnosis of breast, lung, or head and neck cancer - You are scheduled to receive radical radiotherapy (more than 50 Gy) to the chest, breast, or head and neck area You may NOT be eligible if: - You are unable to give informed consent - You have a pre-existing skin rash, ulceration, or open wound in the treatment area - You have systemic skin diseases or allergies that affect the skin, even outside the treatment area - You are allergic to any ingredient in either cream, or failed the patch test Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, purifi

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.

Locations(1)

QLD, Australia

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ACTRN12612000568819