Luo, Y., Feng, M., Fan, Z., Zhu, X., Jin, F., Li, R., . . . Lang, J. (2016). Effect of Kangfuxin solution on chemo/radiotherapy-induced mucositis in nasopharyngeal carcinoma patients: A multicenter, prospective randomized phase III clinical study. Evidence-Based Complementary and Alternative Medicine, 2016, 8692343. 

DOI Link

Study Purpose

To evaluate the efficacy and safety of Kangfuxin solution, a pure Chinese herbal medicine, on mucositis induced by chemo/radiotherapy in patients with nasopharyngeal carcinoma

Intervention Characteristics/Basic Study Process

The treatment patients gargled three times a day after each meal. Patients were monitored from the first day of chemotherapy or radiotherapy until the emergence of grade 3 oral mucositis or when the patients finished the entire course of radiotherapy using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Oral mucositis and pain were measured according to guidelines.

Sample Characteristics

  • N = 215   
  • AGE = 46.3 years (SD = 11)  
  • MALES: 62 (28.8%), FEMALES: 153 (71.2%) 
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

Randomized, parallel-group clinical trial

Measurement Instruments/Methods

  • CTCAE, version 3.0 
  • Verbal rating scale (VRS) 
  • Karnofsky Performance Scale

Results

The incidence and severity of oral mucositis in the test group significantly reduced (p = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in the test group (p < 0.01). Comparing the grades of oral mucositis, the test drug also was shown to reduce the severity of oral mucositis (p = 0.0098), and the accumulated radiation dose was also higher in the test group compared to the control group (p < 0.05). The test group showed a lower incidence of oral pain and gastrointestinal mucositis than the control group (p < 0.01). No significant adverse events were observed.

Conclusions

Kangfuxin solution reduced the incidence of all levels of mucositis, especially high-grade mucositis, to improve patients' tolerance to radiation, ensuring the continuity of radiotherapy. So, it demonstrated its superiority to compound borax gargle on mucositis induced by chemo/radiotherapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Control intervention not standard

Nursing Implications

Kangfuxin solution effectively prevented chemo/radiotherapy-induced oral mucositis, reduced the incidence of upper gastrointestinal inflammation, and decreased the severity of oral pain compared with compound borax gargle. It improves the quality of life in patients. Additional research to confirm the effects is warranted.