Efficacy of Esomeprazole Cream in Preventing Radiation-Induced Dermatitis in Cancer Patients.

CONTEXT: Prevention of radiation-induced dermatitis (RID) and reduction of its severity can improve outcomes for cancer patients undergoing radiotherapy.

OBJECTIVES

This randomized, placebo-controlled clinical trial investigated the efficacy and safety of 2% esomeprazole cream in preventing acute RID in patients with head and neck cancer.

METHODS

In the first phase, 2% esomeprazole cream was developed and its physical, sensory, and chemical properties were evaluated. In the second phase, 36 patients with head and neck cancer meeting the inclusion and exclusion criteria were randomly assigned to receive 2% esomeprazole cream (n = 18) or placebo (n = 18). RID severity was assessed using the Radiation Therapy Oncology Group (RTOG) scale; skin burn and dryness were evaluated using CTCAE v5.0 criteria. Pain and quality of life were measured with the Visual Analog Scale (VAS) and the Dermatology Life Quality Index (DLQI), respectively.

RESULTS

2% Esomeprazole cream significantly reduced RID severity and delayed the onset of acute dermatitis compared with placebo. Additionally, the esomeprazole cream markedly reduced post-radiation skin burning, dryness, and pain over an 8-week follow-up. However, there was no significant effect on patients' overall quality of life as measured by DLQI.

CONCLUSION

Administration of 2% esomeprazole cream to head and neck cancer patients undergoing radiotherapy appears to reduce RID severity and delay onset, with favorable effects on several cutaneous symptoms. Further larger, multicenter trials are warranted to confirm these findings and to evaluate long-term outcomes and quality of life.