Yamauchi, K., Kogashiwa, Y., Moro, Y., & Kohno, N. (2014). The effect of topical application of royal jelly on chemoradiotherapy-induced mucositis in head and neck cancer: A preliminary study. International Journal of Otolaryngology, 2014, 974967. 

DOI Link

Study Purpose

To test the effectiveness of royal jelly on the prevention of mucositis in patients with head and neck cancer receiving chemotherapy and radiation

Intervention Characteristics/Basic Study Process

The royal jelly (RJ) was collected from the species Apis mellifera with a primary diet of nectar and pollen from flowers in China. Patients in the intervention group applied 1 g of royal jelly three times per day for the duration of radiation treatment (RT), and patients in the control group did not apply royal jelly. Data were collected during radiation twice per week and one month after radiation was complete.

Sample Characteristics

  • N = 13  
  • AGE RANGE = 51–84 years
  • MALES: 92.3%, FEMALES: 7.6%
  • KEY DISEASE CHARACTERISTICS: Hypopharyngeal, oropharyngeal, laryngeal, oral cavity squamous cell carcinoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Three different chemotherapy regimens; radiation therapy dose 33–35 fractions (60–70 Gy)

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: Kyorin University School of Medicine, Tokyo, Japan

Phase of Care and Clinical Applications

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

Study Design

Randomized, single-blinded (physician-blinded) trial

Measurement Instruments/Methods

  • Inspection 
  • Fiberscope 
  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3 used to grade mucositis

Results

In the control group, 100% (six) patients experienced grade 3 oral mucositis at the end of radiation compared to the 71.4% (five) who experienced grade 3 in the RJ group and the 28.6% (two) who experienced grade 2 mucositis in the RJ group. RJ delayed the progression to grade 2 mucositis (19 ± 4.1 days in the RJ group, 25.9 ± 9.6 days in the control group, p < .001). RJ also significantly delayed the progression to grade 3 mucositis (37.4 ± 11.8 days in the RJ group, 31 ± 5.8 days in the control group, p < .001).

Conclusions

The results of this study suggest that the topical application of RJ is effective in preventing accelerated mucositis induced by chemoradiotherapy.

Limitations

  • Small sample (< 30)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: Different chemotherapy regimens; no description of regimens; RT dose may have differed based on the disease site

Nursing Implications

Chemoradiotherapy for head and neck cancer continues to cause significant mucositis, which is debilitating and can impact nutritional status, comfort, and often patients' ability to complete therapy without treatment breaks. The topical administration of RJ offers one intervention that could improve this side effect; however, further studies are needed to support these findings.