Jiang, C., Wang, H., Xia, C., Dong, Q., Chen, E., Qiu, Y., . . . Chen, T. (2018). A randomized, double-blind, placebo-controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma. Cancer, 125, 1081-1090.

DOI Link

Study Purpose

The purpose was to evaluate a probiotic combination on the severity of oral mucositis in patients with nasopharyngeal cancer who are undergoing concurrent chemotherapy and radiation therapy.

Intervention Characteristics/Basic Study Process

Probiotic combination (Bifidobacterium longum, Lactobacillus lactis, and Enterococcus faecium) three capsules BID from the beginning of treatment to end of treatment, up to 7 weeks.

Sample Characteristics

  • N = 99 (2:1 randomization, n = 64 in probiotic group and n = 35 in placebo group)   
  • MEAN AGE: 50.4  years in treatment group and 51.69 years in placebo group
  • MALES: N = 58 (n = 21 [60%] in treatment group, n = 37 (64%] in control group)  
  • FEMALES: N = 35 (n = 14 [40%] in treatment group, n = 21 [36%] in control group)
  • CURRENT TREATMENT: Combination radiation therapy and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: n/a

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

RCT, double-blind, placebo controlled

Measurement Instruments/Methods

Mucositis was measured with the CTCAE, version 4.0, by two senior radiation oncologists daily. Routine blood analysis, biochemical analysis, and lymphocyte immunity were measured before and after treatment.

Results

Patients in the intervention group showed a significant reduction in the severity of OM. The incidences of grade 0, 1, 2, and 3 OM in the placebo group and the probiotic combination group were 0% and 12%, 0% and 55%, 54% and 17%, and 46% and 16%, respectively. Additional genomic and biochemical analysis results reported.

Conclusions

The probiotic combination significantly reduced oral mucositis. Blood test results found that this reduction may be due to improvements in immunity. The optimal dose and schedule still needs to be explored.

Nursing Implications

Probiotics have the potential to improve outcomes related to oral mucositis in patients receiving combination chemotherapy and radiotherapy for nasopharyngeal cancer. Additional research is needed to identify the ideal dose and schedule for this treatment.