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

NCT05918224 | Completed Phase 2

• 1 other identifier: ChiCTR2100054689
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; nasopharyngeal carcinoma; oral mucositis; Streptococcus salivarius K12

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.

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

Secondary Outcomes (9)

• Taste function

  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

• Xerostomia

  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

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

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

Study Arms (2)

Experimental group

EXPERIMENTAL

S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).

Drug: Streptococcus salivarius K12

Placebo group

PLACEBO COMPARATOR

Placebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).

Drug: Streptococcus salivarius K12 simulants

Interventions

Streptococcus salivarius K12 DRUG

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.

Also known as: OralBiotic BLIS K12 (NOW Foods, USA)

Experimental group

Streptococcus salivarius K12 simulants DRUG

Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Stomatitis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 18, 2022
• First Posted: June 26, 2023
• Study Start: January 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)