Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

NCT06390176 | Recruiting

• 1 other identifier: 2023-1747
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body. Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10\^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• The incidence of Severe Oral mucositis (WHO grade ≥3)

  Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.

  From the start of radiotherapy to 8 weeks after completion of radiotherapy

Secondary Outcomes (7)

• The time to onset of Severe Oral mucositis (WHO grade ≥3)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy

• The duration of Severe Oral mucositis (WHO grade ≥3)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy

• Xerostomia summated xerostomia inventory (SXI)

  1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy

• Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire

  1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy

• Adverse events

  From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Placebo-containing tablets

Dietary Supplement: Placebo-containing tablets; Radiation: Radiotherapy

Experimental group

EXPERIMENTAL

Lactobacillus rhamnosus GG (LGG)

Dietary Supplement: Lactobacillus rhamnosus GG powder; Radiation: Radiotherapy

Interventions

Lactobacillus rhamnosus GG powder DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG powder (PROBIOTICS Powder, USA) contained no less than 5×10\^8 CFU viable cells of Lactobacillus rhamnosus GG as the active ingredient.

Experimental group

Placebo-containing tablets DIETARY_SUPPLEMENT

Starch preparations that look and taste like Lactobacillus rhamnosus GG powder

Control group

Radiotherapy RADIATION

One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy, with radiotherapy using intensity-modulated radiotherapy techniques.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Stomatitis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

+86 18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 30, 2024
• Study Start: November 10, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)