Can a probiotic shield cancer patients from radiation mouth sores?
NCT ID NCT06390176
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Radiation for head and neck cancer often causes painful mouth sores called oral mucositis. Researchers are testing whether a probiotic, Lactobacillus rhamnosus GG, can prevent severe cases. The trial enrolls 160 adults with head and neck cancer who are scheduled for radiation. Half receive the probiotic powder and half receive a placebo, and doctors track who develops severe mouth sores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lactobacillus rhamnosus GG probiotic powder
- What this could lead to
- If it works, this could offer a simple, low-risk probiotic to reduce severe mouth sores during head and neck radiation.
- What could go wrong
- This is a mid-stage trial, and probiotics may not prevent mucositis or may not help all patients. Results could differ from earlier small studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
160 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Head and neck cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Mouth device aims to keep Sore-Relief rinses where They're needed
- Five days of radiation instead of weeks: a new test for head and neck cancer