Rose geranium in sesame oil nasal spray to improve symptoms of nasal vestibulitis: A phase III double blinded randomized controlled trial.

person Elizabeth Jane Cathcart-Rake Department of Medical Oncology, Mayo Clinic, Rochester, MN info_outline Elizabeth Jane Cathcart-Rake, Paul J. Novotny, Deanne R. Smith, Susan E. Lewis-Peters, Karthik Giridhar, Kimberly O. Steinert, Darcie Dauer, Amanda K. O'Connor, Stephan Thome, Terra A. Register, Marsha K. Erickson, Bret Edward Buckley Friday, Charles L. Loprinzi

Authors person Elizabeth Jane Cathcart-Rake Department of Medical Oncology, Mayo Clinic, Rochester, MN info_outline Elizabeth Jane Cathcart-Rake, Paul J. Novotny, Deanne R. Smith, Susan E. Lewis-Peters, Karthik Giridhar, Kimberly O. Steinert, Darcie Dauer, Amanda K. O'Connor, Stephan Thome, Terra A. Register, Marsha K. Erickson, Bret Edward Buckley Friday, Charles L. Loprinzi Organizations Department of Medical Oncology, Mayo Clinic, Rochester, MN, Mayo Clinic, Rochester, MN, Essentia Health, Brainerd, MN, Mayo Clinic, Mankato, MN, Essentia Health, Duluth, MN Abstract Disclosures Research Funding Other Foundation Breast Cancer Research Foundation (BCRF) and the Minnesota Cancer Clinical Trials Network (MNCCTN) Background: A retrospective study suggested a potential benefit from rose geranium in sesame oil nasal spray for alleviating nasal vestibulitis symptoms in patients (pts) undergoing chemotherapy. Methods: Pts undergoing active chemotherapy who reported moderate or worse nasal symptoms were randomized 1:1 to receive a rose geranium in sesame oil nasal spray (RG) or an isotonic saline nasal spray (IS), administered twice daily for two weeks. Consenting pts completed nasal symptom questionnaires at baseline and then weekly while on treatment. The number and percentage of pts experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, defined as symptoms moderately (2) or very much (3) better on a 7-point global impression of change score (ranging from scores of -3: very much worse, to 3: very much better), was estimated within and then between each randomized arm, using Fisher’s exact test (5% significance level). The estimated odds ratio was determined (95% confidence interval). After 2 weeks, pts initially randomized to IS were allowed to cross-over to RG and completed weekly surveys. Results: 106 pts consented to this study; 43 pts in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Pts had a mean age of 57.8 (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. The most prominent baseline nasal symptoms were dryness (36%) and bleeding (35%). Of the 43 evaluable pts who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the 41 pts who received IS (p=0.009; Table). On the global impression of change score, pts who received RG had a mean score of 1.93 (SD 1.16), compared to a mean score of 0.98 (SD 1.41) among pts who received IS. Adjusting for potential confounding factors, pts who received RG had a 4.56 odds of responding to the nasal spray, compared with those who received IS (p=0.005). There were no significant differences between pt responses based upon type of nasal symptoms, age, allergies, or gender. Adverse events were sparse and did not differ between arms. 34 pts crossed over to RG after week 2. Among the 29 pts who completed final surveys, 37% reported a response on IS, 79% reported a response on RG. Conclusions: Rose geranium in sesame oil nasal spray significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy. Clinical trial information: NCT04620369. Global Impression of Change Score Scale Value Rose Geranium in Sesame Oil (N=43) N (%) Isotonic Saline (N=41) N (%) Very Much Worse -3 0 0 Moderately Worse -2 1 (2.3%) 3 (7.3%) A Little Worse -1 1 (2.3%) 1 (2.4%) About the Same 0 1 (2.3%) 12 (29.3%) A Little Better 1 11 (25.6%) 10 (24.4%) Moderately Better 2 12 (27.9%) 8 (19.5%) Very Much Better 3 17 (39.5%) 7 (17.1%)

Clinical