Zheng, B., Zhu, X., Liu, M., Yang, Z., Yang, L., Lang, J., . . . Zhu, G. (2018). Randomized, double-blind, placebo-controlled trial of Shuanghuabaihe tablets to prevent oral mucositis in patients with nasopharyngeal cancer undergoing chemoradiation therapy. International Journal of Radiation Oncology, Biology, Physics, 100, 418–426.

DOI Link

https://doi.org/10.1016/j.ijrobp.2017.10.013

Study Purpose

To evaluate if Shaunghaubaihe tablets can prevent oral mucositis for patients with locally advanced nasopharyngeal carcinoma undergoing chemoradiotherapy.

Intervention Characteristics/Basic Study Process

Multi-site, randomized, double blind study of Shuanghuabaihe tablets versus placebo (four tablets, three times a day) started at the initiation of chemoradiotherapy and lasting seven weeks. Patients could stop taking the tablets if grade 3 mucositis developed.

Sample Characteristics

N = 240
AGE: 18-70 years old
MALES: 70% (intervention) and 63.03% (placebo)
FEMALES: 30% (intervention) and 36.97% (placebo)
CURRENT TREATMENT: Combination radiation and chemotherapy
KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma

Setting

SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

RCT. Patients age 18-70 years with locally advanced nasopharygeal carcinoma randomly assigned to receive Shaunghaubaihe tablets or a placebo, starting at the initiation of chemoradiation.

Measurement Instruments/Methods

The incidence of different stages of mucositis was compared using Fisher’s exact test and the 95% confidence intervals. The Kaplan-Meier method was used to estimate the median time of the occurrence of OM (latency). To compare latency, the Cox proportional hazard model was used for hazard ratio (HR) and 95% CI values. One-way ANOVA and Fisher’s exact were used to compare toxicities and secondary efficacy endpoints. All data was analyzed using SAS, version 9.2, software.

Results

Shaunghaubaihe tablets significantly reduced the incidence, latency, and severity of oral mucositis in patients with nasopharyngeal cancer.

Limitations

Two patients from placebo and eight from treatment arm did not complete the entire course of radiation therapy. This is an initial study and further clinical study is needed to evaluate and verify therapeutic effects.

Nursing Implications

Therapeutic agents that prevent oral mucositis are needed because systemic oral care alone is insufficient.