Randomized, Double-blind, Placebo-Controlled Trial of Shuanghuabaihe Tablets to Prevent Oral Mucositis in Patients with Nasopharyngeal Cancer Undergoing Chemoradiotherapy

International Journal of Radiation Oncology Biology Physics

5 years ago

Randomized, Double-blind, Placebo-Controlled Trial of Shuanghuabaihe Tablets to Prevent Oral Mucositis in Patients with Nasopharyngeal Cancer Undergoing Chemoradiotherapy

Oral mucositis is a common, unpreventable complication associated with chemoradiotherapy. Shuanghuabaihe tablets have been approved by Chinese Food and Drug Administration for treating recurrent oral mucosa ulceration. This study is to assess whether Shuanghuabaihe tablets could prevent oral mucositis during chemoradiotherapy for locally advanced nasopharyngeal carcinoma.

Patients and Methods

This multi-centre, randomized, double-blind, placebo-controlled trial was conducted at 11 hospitals in China between January 22nd, 2014 and September 21st, 2015. Eligible patients (n = 240, 18 - 70 years old) with pathologically diagnosed locally advanced nasopharyngeal carcinoma were randomly assigned (computer-block randomization; 1:1) to receive Shuanghuabaihe tablets or placebo (four tablets, three times a day, for seven weeks) at the time from initiation of chemoradiotherapy. Administration of Shuanghuabaihe tablets could be ended if patients developed ≥ grade 3 oral mucositis and were unwilling to continue taking the drug. Primary end points were oral mucositis incidence and latency.

Results

The incidence of oral mucositis during this study was significantly lower in the Shuanghuabaihe group (85.0%, 95% CI 78.6∼91.4) compared with that in the placebo group (96.6%, 95% CI 93.4∼99.9; P=0.0028). Median latency was 28 days in the Shuanghuabaihe group and 14 days in the placebo group (HR 0.17, 95% CI 0.12∼0.23; P<0.0001). Compared with the placebo, Shuanghuabaihe tablets significantly reduced oral mucositis severity scores recorded by investigators (24.0 [0.0∼67.8] vs.57.5 [0.0∼98.0], P<0.0001), full-time nurses (OAG: 462.0 [392.0∼664.7] vs.520.4 [392.0∼714.0], P<0.0001) and patients (soreness of the mouth and throat: 4.0 [0∼10] vs.6.0 [0∼10], P<0.0001). No serious adverse events were observed and the incidence of mild/moderate gastrointestinal adverse events associated with Shuanghuabaihe tablets was 3.3%.The short-term response rate is similar in patients with Shuanghuabaihe tablets and with placebo during chemoradiotherapy during this study.

Conclusion

Shuanghuabaihe tablets reduced the occurrence, latency and severity of oral mucositis in patients with nasopharyngeal cancer during chemoradiotherapy treatment.

Teaser

Shuanghuabaihe tablets have been used for treating recurrent oral mucosa ulceration.Eligible patients (n=240, 18-70 years old) with pathologically diagnosed locally advanced nasopharyngeal carcinoma were randomly assigned (computer-block randomization; 1:1) to receive Shuanghuabaihe tablets or placebo (four tablets, three times a day, for seven weeks) at the initiation of chemoradiotherapy.Shuanghuabaihe tablets reduce the occurrence, latency and severity of oral mucositis in patients with nasopharyngeal cancer during chemoradiotherapy treatment.

Publisher URL: www.sciencedirect.com/science

DOI: S0360301617339779