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<p>Chemotherapy-induced oral mucositis impairs quality of life. Although probiotics may alleviate severe oral mucositis, previous studies mainly examined high-risk settings, such as hematopoietic stem cell transplantation. Prospective evidence for outpatient breast cancer chemotherapy remains limited. We examined the association of <i>Lactobacillus reuteri</i> lozenges with oral mucositis in patients receiving anthracycline- or taxane-based chemotherapy for breast cancer. This single-center, exploratory, open-label, randomized controlled trial included a control group that did not receive lozenges. Patients were assigned to the <i>L. reuteri</i> or control group, and received <i>L. reuteri</i> lozenges twice daily for 12&#xa0;weeks or no intervention. The primary outcome was Grade ≥ 2 oral mucositis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0. Sixty-seven patients were randomized, with 61 analyzed. Grade ≥ 2 oral mucositis incidence was not significantly different between the groups in cycles 1 and 2, whereas that in the <i>L. reuteri</i> group was lower in cycles 3 and 4 (22.6% vs. 50.0%, 19.4% vs. 43.3%, respectively). A mixed-effects model did not show a statistically significant time-by-intervention effect. No intervention-related adverse events occurred. These exploratory findings suggest that <i>L. reuteri</i> lozenge use may be associated with lower incidence of Grade ≥ 2 oral mucositis in cycle-specific comparisons.</p>

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Lactobacillus reuteri lozenges and chemotherapy-induced oral mucositis in breast cancer outpatients: an exploratory randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月11日

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  • Hiromi Nishi,
  • Susumu Horikoshi,
  • Shinsuke Sasada,
  • Yuki Kuwabara,
  • Kouji Ohta,
  • Hideo Shigeishi,
  • Yukio Yoshioka,
  • Masaru Konishi,
  • Marino Yoshida,
  • Tetsuya Yoshimoto,
  • Kanako Yano,
  • Miyuki Nakaoka,
  • Hideo Shigematsu,
  • Kotaro Tanimoto,
  • Naoya Kakimoto,
  • Hiroki Ohge,
  • Hiroyuki Kawaguchi

摘要

Chemotherapy-induced oral mucositis impairs quality of life. Although probiotics may alleviate severe oral mucositis, previous studies mainly examined high-risk settings, such as hematopoietic stem cell transplantation. Prospective evidence for outpatient breast cancer chemotherapy remains limited. We examined the association of Lactobacillus reuteri lozenges with oral mucositis in patients receiving anthracycline- or taxane-based chemotherapy for breast cancer. This single-center, exploratory, open-label, randomized controlled trial included a control group that did not receive lozenges. Patients were assigned to the L. reuteri or control group, and received L. reuteri lozenges twice daily for 12 weeks or no intervention. The primary outcome was Grade ≥ 2 oral mucositis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0. Sixty-seven patients were randomized, with 61 analyzed. Grade ≥ 2 oral mucositis incidence was not significantly different between the groups in cycles 1 and 2, whereas that in the L. reuteri group was lower in cycles 3 and 4 (22.6% vs. 50.0%, 19.4% vs. 43.3%, respectively). A mixed-effects model did not show a statistically significant time-by-intervention effect. No intervention-related adverse events occurred. These exploratory findings suggest that L. reuteri lozenge use may be associated with lower incidence of Grade ≥ 2 oral mucositis in cycle-specific comparisons.