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Streptococcus salivarius K12 Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial.

  • 2024-04-20
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology 42(12)
    • Xingchen Peng
    • Zixia Li
    • Yiyan Pei
    • Shuhao Zheng
    • Jinchi Liu
    • Jingjing Wang
    • Ruidan Li
    • Xin Xu

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 160
Population
160 patients with malignant head and neck tumors undergoing definitive or postoperative adjuvant RT
Methods
Prospective, randomized, double-blind, placebo-controlled trial; patients were randomly assigned (1:1) to receive SsK12 probiotic (n = 80) or placebo (n = 80) and instructed to suck SsK12 or placebo lozenges thrice daily from the initiation to the end of RT; OM was evaluated twice a week during RT and once a week thereafter for up to 8 weeks
  • Large Human Trial

Purpose

Oral mucositis (OM) is a common debilitating toxicity associated with radiotherapy (RT) for malignant head and neck tumors. This prospective, randomized, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of Streptococcus salivarius K12 (SsK12) in reducing the incidence, duration, and severity of severe OM (SOM).

Methods

A total of 160 patients with malignant head and neck tumors undergoing definitive or postoperative adjuvant RT were randomly assigned (1:1) to receive SsK12 probiotic (n = 80) or placebo (n = 80) at West China Hospital, Sichuan University, Chengdu, China. Patients were instructed to suck SsK12 or placebo lozenges thrice daily from the initiation to the end of RT. OM was evaluated twice a week during RT and once a week thereafter for up to 8 weeks. The primary end point was the incidence of SOM. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

Results

Baseline patient characteristics were similar in the SsK12 and placebo groups. The incidence of SOM was significantly lower in the SsK12 group as compared with the placebo group (36.6% v 54.2%; P = .0351). The duration (median, 0.0 days v 7.0 days; mean, 8.9 days v 18.3 days; P = .0084) and time to develop SOM (median, not estimable v 42.0 days; hazard ratio, 0.55 [95% CI, 0.34 to 0.89]; log-rank test: P = .0123) were also improved in the case of the SsK12 group. Adverse events were similar between the groups, and mild or moderate gastrointestinal reactions (flatulence or dyspepsia) associated with the lozenges were observed in two patients in the SsK12 group. High-throughput sequencing results indicated that SsK12 inhibited opportunistic pathogens and enriched oral commensals during RT.

Conclusion

In this prospective, randomized clinical trial, SsK12 probiotic significantly reduced the incidence, onset, and duration of SOM with a good safety profile.

Research Insights

  • Streptococcus salivarius K12→Delayed Oral Mucositis Onset

    The duration ... and time to develop SOM (median, not estimable v 42.0 days; hazard ratio, 0.55 [95% CI, 0.34 to 0.89]; log-rank test: P = .0123) were also improved in the case of the SsK12 group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    thrice daily (lozenges)
  • Streptococcus salivarius K12→Reduced Oral Mucositis Severity

    The incidence of SOM was significantly lower in the SsK12 group as compared with the placebo group (36.6% v 54.2%; P = .0351). The duration ... and time to develop SOM ... were also improved in the case of the SsK12 group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    thrice daily (lozenges)
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