The effect of Calendula lotion in reducing the severity of radiation induced dermatitis in women undergoing radiotherapy for breast cancer

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The main aim of this study is to compare two products for preventing or reducing the severity of radiation induced dermatitis (RID). RID is a common side effect of radiation therapy. RID is characterised by skin redness and in severe cases, the skin thins and begins to weep and may be susceptible to infection. With ongoing radiation, the skin condition and appearance often worsens. This trial aims to compare sorbolene cream which is the standard product that is recommended for use by patients at the Royal Adelaide Hospital with a lotion containing extract of Calendula officinalis (marigold flower), called Calendula lotion. Calendula is reported to have anti-inflammatory properties and may encourage skin healing. The hypothesis for the study is that Calendula lotion offers significant benefits compared to sorbolene when used for the prevention or treatment of RID. Who is it for? This study is open to women 18 years and over who have undergone prior lumpectomy or mastectomy and are due to undergo post-surgical radiotherapy for breast cancer using standard treatment pathways. Participants will need to provide informed consent, and not be undergoing any concurrent chemotherapy at the time of participation. Full exclusion criteria for this study can be found in the relevant section of this form. Trial details You will be randomised to receive either Calendula officinalis lotion (marigold extract 32%v/v) or Sorbolene lotion with 10% glycerine, which will be topically applied to skin twice a day every day of the week during radiotherapy treatment (typically a 5 week period) and for up tp 6 weeks. Participants will be instructed to apply lotion generously to entire irradiated skin using an amount approximately in size to a 20cent-50cent piece (dependent on physique).

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