Recove® burn ointment for managing acute radiodermatitis in patients with breast cancer: A double blind randomized controlled trial.

ABSTRACT

Background: Radiodermatitis is the most common complication of radiotherapy. There is no gold standard for managing the radiodermatitis. This study aimed to evaluate the effect of topical Recove® burn ointment; basically compounded of sesame oil, camphor, and zinc oxide; in preventing acute radiodermatitis. Methods: This double blind RCT (IRCT No. 201204047136N2) was performed on 71 patients that referred for radiotherapy after mastectomy to Shahid Rajaee Hospital (Babolsar-Iran) during 2013-2017. Patients were allocated into 2 groups; 34 in control group and 37 in Recove® group. Patients applied the ointment 2 times a day, before every radiation therapy session for 5 weeks. The radiation oncologist assessed the severity of dermatitis weekly for 5 weeks and graded it from 0 to 4 according to the RTOG criteria. Results: Baseline characteristics including age, and BMI had no significant difference between groups. The Recover group patients experienced significantly less severe dermatitis compared to the controls (p<0.001). None of the patients in Recove® group encountered more than grade 2 of RTOG criteria, however, in the control group, 4 (12.9%) patients experienced grade 3 of RTOG and 3 (9.7%) patients developed grade 4 of RTOG at the end of the 5th week. Conclusion: Our results indicate that Recove® ointment significantly reduces the severity of acute radiodermatitis.