Efficacy of Plantago major leaf extract cream compared to placebo in preventing acute radiodermatitis in breast cancer patients: A randomized clinical trial

Abstract

IntroductionDermatitis is a common side effect of radiotherapy (RT). Plantago major L. leaves (P. major) exhibit anti-inflammatory and wound-healing activities. This study aimed to evaluate the preventive effect of P. major on acute radiodermatitis in breast cancer patients. MethodsThis randomized controlled trial involved 78 breast cancer patients who had undergone modified radical mastectomy and were scheduled for RT. After random allocation, the control group (n = 39) received a placebo and the intervention (n = 39) group received P. major cream. It was used as an external application twice per day from the first day of RT until two weeks after the completion of the radiation course. The patients were examined weekly by a physician. The primary outcome was the incidence and severity of acute radiodermatitis, graded according to Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) and National Center Institute Common Terminology Criteria for Adverse Events, version 5 (NCI-CTCAE) toxicity scoring systems. ResultsRadiodermatitis grades ≥2 according to the RTOG/EORTC and NCI-CTCAE scoring systems developed from the third week of RT, peaking in the sixth week in both groups. The incidence of grades ≥2 acute dermatitis was lower in patients treated with topical P. major than with the placebo (51.3% vs. 66.7%), but this difference was not statistically significant (relative risk = 0.769, 95% confidence interval, 0.429–1.373). Dermatitis grades ≥2 had no relationship with body mass index ≥30 and older age. Itching during the six weeks of follow-up was more common in the P. major group. ConclusionThis study revealed that 7% P. major cream did not significantly decrease the severity of acute radiodermatitis. Conducting multicenter trials with larger sample sizes and using different topical agents based on P. major are recommended for future studies. Trial registrationIRCT20150830023823N4.