Lactobacillus Reuteri for treating oral mucositis in head and neck cancer patients undergoing radiation
Lactobacillus Reuteri 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 Reuteri can help reduce painful mouth sores in head and neck cancer patients receiving radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06285591 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Lactobacillus Reuteri in alleviating oral mucositis, a common and painful side effect of radiation therapy in patients with head and neck tumors. The study involves administering Lactobacillus Reuteri tablets to patients undergoing radiotherapy and comparing the outcomes with a placebo group. The goal is to assess whether this probiotic can reduce the severity of oral mucositis and improve the quality of life for these patients. Participants will be closely monitored for changes in their oral health and overall treatment tolerance during their radiation therapy.
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 radiation therapy.
Not a fit: Patients with known allergies to Lactobacillus Reuteri or those with a history of head and neck radiotherapy 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, improving the quality of life for patients undergoing radiation therapy.
How similar studies have performed: While there have been various approaches to managing oral mucositis, the use of Lactobacillus Reuteri specifically in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
- Email: pxx2014@163.com
- Phone: +86 18980606753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.