Clinical trial NCT05918224: Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy
Official title: Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: head and neck squamous cell carcinoma
nasopharyngeal carcinoma
oral mucositis
Streptococcus salivarius K12
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

Detailed description: The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.

Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology;
* Aged 18 to 80 years;
* Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
* Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
* Sign the informed consent

Exclusion Criteria:

* Patients with known allergy to probiotic or severe allergic constitution;
* Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
* Poor oral hygiene and/or severe periodontal diseases;
* Any previous RT to the head and neck region;
* Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Primary outcomes:
measure: The incidence of Severe Oral mucositis (WHO grade ≥3)
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary outcomes:
measure: Taste function
timeFrame: 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
measure: Xerostomia
timeFrame: 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
measure: functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.
timeFrame: 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
measure: Adverse events
timeFrame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
measure: The duration of Severe Oral mucositis (WHO grade ≥3)
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
measure: The time to onset of Severe Oral mucositis (WHO grade ≥3)
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
measure: The number of patients who missed five or more consecutive radiation fractions.
timeFrame: The time period is the period from the start of radiotherapy to the completion of radiotherapy
measure: Mouth and throat soreness (MTS) scores
timeFrame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
measure: Oral activities scores
timeFrame: The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6 1/2 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xingchen Peng
role: PRINCIPAL_INVESTIGATOR
References: