Lactobacillus Rhamnosus GG for Oral Mucositis in Radiotherapy Patients

Lactobacillus Rhamnosus LGG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial

This study is testing if a probiotic called Lactobacillus rhamnosus GG can help reduce painful mouth sores in patients getting radiation for head and neck cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06390176 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Lactobacillus rhamnosus GG (LGG) on alleviating oral mucositis in patients undergoing radiotherapy for head and neck cancers. Oral mucositis is a common and painful side effect of radiation treatment, significantly impacting patients' quality of life and treatment adherence. The study involves administering LGG powder to participants and comparing its effects against a placebo while they receive radiotherapy. The goal is to determine if LGG can reduce the severity of oral mucositis and improve overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with non-metastatic head and neck malignant tumors who are scheduled to receive radiotherapy.

Not a fit: Patients with known allergies to Lactobacillus Reuteri components or those with serious medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of oral mucositis, enhancing the quality of life for patients undergoing radiotherapy.

How similar studies have performed: Previous studies have shown promising results with probiotics in managing oral mucositis, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
2. Aged 18-80 years;
3. Eastern Cooperative Oncology Group performance status of ≤2;
4. Planning to receive definitive RT or postoperative adjuvant RT;
5. Normal liver, kidney and bone marrow function;
6. Sign informed consent.

Exclusion Criteria:

1. Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
2. Those with poor compliance;
3. Pregnancy or breastfeeding;
4. History of head and neck radiotherapy;
5. Taking antifungal or viral medications one week prior to the start of radiation therapy.
6. Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Xingchen Peng — West China Hospital
• Study coordinator: Xingchen Peng

Conditions: Oral Mucositis