Clinical Efficacy on Severe Acute Radiation Dermatitis Treated by Topical Compound Danxiong Granules in Patients Receiving Radiation: A Prospective Randomized Trial

Abstract

<h3>Purpose/Objective(s)</h3> Radiation dermatitis (RD) is one of the most common acute toxicities induced by radiation therapy (RT). The preliminary study demonstrated the Compound Danxiong Granules (CDG), a traditional Chinese medicine, had promising outcome in RD. To evaluate the efficacy of topical CDG in the treatment of ≥ grade 3 acute radiation dermatitis. <h3>Materials/Methods</h3> This prospective, randomized, open-label phase 2 clinical trial (ChiCTR1900021339) enrolled patients who had histologically proven malignant tumor, with grade 3 acute RD in the radiation field within 30 days after radiotherapy, in accordance with the CTCAE 4.0 version. We randomly assigned patients (2:1) to receive either CDG treatment (CDG group), or standard of care of recombinant human epidermal growth factor (Gene Time, control group), using a computer-generated randomization list. Application of the CDG via topical washes lasted 20 minutes, twice daily. Grading of RD was performed by independent radiation oncologist every day. The primary endpoint was the recovery time from grade 3 dropped to grade 1. <h3>Results</h3> 90 patients in our institution were randomized between January 2019 and December 2021. Of 90 patients, 58(64.4%) were assigned to the CDG group and 32(35.6%) to the control group. One (1.7%) patient in the CDG group did not receive allocated treatment and withdrew from the trial. The median recovery time was 11 days in the CDG group versus 26 days in the control group (p<0.001). Significant differences in compliance with RT were observed between the groups (p<0.001). The CDG regimen was well tolerated and did not cause any adverse effects. <h3>Conclusion</h3> Topical application of CDG can effectively relieve severe acute radiation dermatitis rapidly and shorten recovery time significantly compared to traditional treatment.