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Objective: Radiotherapy of cancers are usually accompanied by some form of radiation induced skin toxicity (radiation dermatitis) in most patients receiving this type of treatment. It can vary from very mild disease to extensive and severe dermatitis limiting further treatment. It is therefore obvious that preventative care will optimise the outcome of radiation of the tumour while the skin’s integrity is preserved leading to a better clinical outcome overall. Methods: In Vitro: In the study a newly developed silicone topical device (RT-Gel Sun Pharma South Africa), is compared to a similar product StrataXRT as well as to a negative control group of no gel. Gels were tested to observe the effect on the radiation dose provided. All gels were applied as a thin layer to the surface of the bolus within the Farmer Chamber. In Vivo: In this multicentre study a newly developed silicone topical device (RT-Gel® Sun Pharma South Africa), applied as a thin layer gel, is compared to a similar product StrataXRT as well as to standard of care in practice. The aim was to compare patients’ preferences of treatment modalities as well as establishing differences in clinical outcomes focussing on grades of skin toxicity after radiation therapy. Patients were recruited at radiation oncology sites after being prescribed radiation dosages with curative intent for mostly breast and head and neck cancers. Results: In Vitro: The uncertainties pertaining to the theoretical dose changes and radiation measurements indicates clearly the differences caused by the application of a silicone-based gel during radiotherapy is small enough to be regarded as negligible. In Vivo: The primary outcomes demonstrate the patient’s satisfaction with RT-Gel® i.e. a significant preference for RT-Gel compared to both StrataXRT® (p< 0.02) and standard of care (p< 0.001). The clinicians’ toxicity scores also favoured RT-Gel® over StrataXRT (p< 0.04 ANOVA). Conclusion: It can thus be concluded that preventative treatment with RT-Gel® is at least as effective if not better than competitors, well tolerated and preferred by patients. . It furthermore indicates that dose is not affected by gel and that washing of treated area before next treatment is not required to “prevent build-up of gel”. |
