Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918224
• Other study ID #: ChiCTR2100054689
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Mucositis
• Squamous Cell Carcinoma of Head and Neck
• Stomatitis

Intervention

Drug:
• Streptococcus salivarius K12
The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.
• Streptococcus salivarius K12 simulants
Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary	Taste function	Electrogustometer test and taste strips test.	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
Secondary	Xerostomia	Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.	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
Secondary	functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.	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
Secondary	Adverse events	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version	From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
Secondary	The duration of Severe Oral mucositis (WHO grade =3)	The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days.	From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary	The time to onset of Severe Oral mucositis (WHO grade =3)	Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks.	From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary	The number of patients who missed five or more consecutive radiation fractions.	The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.	The time period is the period from the start of radiotherapy to the completion of radiotherapy
Secondary	Mouth and throat soreness (MTS) scores	Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms.	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
Secondary	Oral activities scores	Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms.	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