1. Efficacy of topical Calendula officinalis on prevalence of radiation‐induced dermatitis: A randomised controlled trial
- Author
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Scott Carruthers, Michael Penniment, Shihab Siddiquee, Robyn Clothier, Eileen Giles, Andrew D. Vincent, Margaret A. McGee, Siddiquee, Shihab, McGee, Margaret A, Vincent, Andrew D, Giles, Eileen, Clothier, Robyn, Carruthers, Scott, and Penniment, Michael
- Subjects
Adult ,medicine.medical_specialty ,Standard of care ,Administration, Topical ,Breast Neoplasms ,Dermatology ,Breast cancer radiotherapy ,law.invention ,Ointments ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Calendula ,0302 clinical medicine ,Primary outcome ,adjuvant ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Single-Blind Method ,radiotherapy ,Aged ,ointments/thera-peutic ,calendula ,biology ,Plant Extracts ,business.industry ,Radiation-Induced Dermatitis ,Middle Aged ,biology.organism_classification ,radiodermatitis ,Calendula officinalis ,030220 oncology & carcinogenesis ,Female ,Radiodermatitis ,business ,randomised controlled trial ,Phytotherapy ,Case analysis - Abstract
Objectives: A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy. Methods: A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation. Results: The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10). Conclusion: This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison. Refereed/Peer-reviewed
- Published
- 2020
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