A randomized controlled trial of probiotics to reduce the severity of oral mucositis in patients with oropharyngeal carcinoma undergoing concurrent chemoradiotherapy.
- 2026-01
- Journal of cancer research and therapeutics 22(1)
- Saloni Sojitra
- Tej Prakash Soni
- Nidhi Patni
- Dinesh Kumar Singh
- Naresh Jakhotia
- Sheh Rawat
- Anil Kumar Gupta
- Tara Chand Gupta
- Naresh Ledwani
- Harish Singhal
- Shantanu Sharma
- Ravindra Singh Gothwal
- PubMed: 41910295
- DOI: 10.4103/jcrt.jcrt_1070_25
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 70
- Population
- 70 patients of carcinoma of the oropharynx
- Methods
- Randomized to probiotics arm (n=35) receiving 65 ml of probiotic milk beverage (Yakult) containing 6.5 billion colony-forming units Lactobacillus casei Shirota strain once a day for 7 weeks during chemoradiotherapy, or control arm (n=35) receiving concurrent chemoradiotherapy alone; all patients received radiotherapy 70 Gy in 35 fractions with concurrent weekly cisplatin
- Duration
- 7 weeks
- Funding
- Unclear
Background
While probiotics show promise in reducing chemoradiotherapy side effects like oral mucositis in head and neck cancer patients, robust clinical evidence of their consistent effectiveness is still needed. The objectives of this study were to compare the incidence and severity of oral mucositis, dysphagia, and compliance of radiotherapy treatment between the study arm (oral probiotics, along with concurrent chemoradiotherapy) and the control arm (concurrent chemoradiotherapy alone) in patients of locally advanced carcinoma oropharynx.Materials and methods
A total of 70 patients of carcinoma of the oropharynx were randomized to the probiotics arm (study arm, n = 35) and the non-probiotics arm (control arm, n = 35). All patients received radiotherapy to a total dose of 70 Gy in 35 fractions, along with concurrent weekly cisplatin chemotherapy. Patients in the probiotics arm were given 65 ml of probiotic milk beverage (Yakult) containing 6.5 billion colony-forming units Lactobacillus casei Shirota strain to drink once a day for 7 weeks during chemoradiotherapy treatment.Results
Incidence of severe mucositis, dysphagia, and significant weight loss was significantly lower in the probiotics arm compared to the control arm. Patients in the probiotics arm experienced significantly less grade 3 oral mucositis (four patients, 11.43%) and grade 3 dysphagia (six patients, 17.14%) compared to patients in the control arm (12 patients, 34.29% and 13 patients, 37.14%, respectively; P < 0.001). Compliance was not statistically different in both the arms.Conclusion
In this randomized clinical trial of carcinoma oropharynx patients, probiotics reduced the concurrent chemoradiotherapy-induced severe oral mucositis and dysphagia.Research Insights
Compliance was not statistically different in both the arms.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 6.5 billion CFU/day (65 ml Yakult)
Incidence of severe mucositis, dysphagia, and significant weight loss was significantly lower in the probiotics arm compared to the control arm.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 6.5 billion CFU/day (65 ml Yakult)
Patients in the probiotics arm experienced significantly less grade 3 oral mucositis (four patients, 11.43%) and grade 3 dysphagia (six patients, 17.14%) compared to patients in the control arm (12 patients, 34.29% and 13 patients, 37.14%, respectively; P < 0.001).
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 6.5 billion CFU/day (65 ml Yakult)
Incidence of severe mucositis, dysphagia, and significant weight loss was significantly lower in the probiotics arm compared to the control arm.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 6.5 billion CFU/day (65 ml Yakult)