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A single-center, open-label, randomized controlled clinical trial of Streptococcus salivarius K12 to reduce severe oral mucositis due to intensity modulated radiotherapy for head and neck squamous cell carcinoma (include nasopharyngeal carcinoma)

A single-center, open-label, randomized controlled clinical trial of Streptococcus salivarius K12 to reduce severe oral mucositis due to intensity modulated radiotherapy for head and neck squamous cell carcinoma (include nasopharyngeal carcinoma)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054689
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-10
Completion date
Unknown
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous cell carcinoma (include nasopharyngeal carcinoma)

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) diagnosed by histopathology; 2. Aged 18 to 80 years; 3. Systemic functional status ECOG rating =100g/L, platelets >=80x10^9/L, white blood cell count >=3.0x10^9/L; 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to the probiotics of Streptococcus salivarius K12 or severe allergic constitution; 2. Poor compliance; 3. Pregnant or breastfeeding; 4. Any previous radiotherapy to the head and neck region; 5. Anti-mycotic/antiviral drugs within 1 week of treatment start; 6. Patients deemed unsuitable for the study by the investigator (concomitant with any serious other disease).

Design outcomes

Primary

MeasureTime frame
Oral mucositis grade;

Secondary

MeasureTime frame
Taste function;Xerostomia;Quality of life;Adverse events;

Countries

China

Contacts

Public ContactPeng Xingchen

West China Hospital, Sichuan University

pxx2014@163.com+86 18980606753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026