S. Siddiquee1, M.A. McGee2, A.D. Vincent2
Objectives: A randomised controlled trial (RCT) was undertaken to compare the efﬁcacy of topical Calendula ofﬁcinalis (Calendula) versus standard of care (Sorbolene) in reducing the prevalence of radiation induced dermatitis (RID) in women undergoing radiotherapy for breast can- cer. Additionally, a review of RCTs examining the use of topical Calendula for RID and subsequently a meta-analy- sis was undertaken.
Methods: The RCT was conducted in the radiotherapy department of the Royal Adelaide Hospital. 272 women were screened, of which 82 were randomised. The primary outcome was the prevalence of acute RTOG (Radiation Therapy Oncology Group) grade 2 + RID assessed at multi- ple skin sites. A v2 test was conducted for the primary out- come with a worst-case scenario imputation. For the meta- analysis, PubMed, MEDLINE and Embase databases were searched to identify relevant RCTs.
Results: RCT: With one withdrawal of consent, 81 partici- pants were analysed (n = 40 Calendula and n = 41 Sor- bolene). There was no detectable difference in the prevalence of RID 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). Meta- analysis: Four studies were identiﬁed (n = 793 partici- pants). A random effects meta-analysis indicated a non-sig- niﬁcant reduction in the prevalence of grade 2 + RID with Calendula.
Conclusions: The RCT and meta-analysis results sug- gested Calendula was not superior, but possibly non-infer- ior, to standard of care for RID prevention.