Nasopharyngeal carcinoma
Conditions
Interventions
Natural microbial exposure group (control group):No additional intervention
Streptococcus salivarius K12 group (SsK12 group):Streptococcus salivarius K12 supplementary
Streptococcus salivarius M18 group (SsM18 group):Streptococcus salivarius M18 supplementary
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed with histologically confirmed stage III-IVa NPC according to the 8th edition of the AJCC staging system; 2. No prior surgical intervention for nasopharyngeal tumor (unless it is a biopsy surgery) 3. Aged between 18 and 70 years 4. Karnofsky Performance Status (KPS) score >= 70 5. Provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Significant organ dysfunction or major comorbidities, including but not limited to metabolic syndrome, hemodialysis, organ transplantation status, diabetes mellitus, ischemic heart disease, infectious diseases such as human immunodeficiency virus (HIV) infection or tuberculosis, thyroid or other endocrine disorders, and autoimmune diseases 2. History of long-term use of immunosuppressive agents or corticosteroids (>=3 months) 3. Presence of another active malignancy 4. Patients with severe pre-existing oral conditions (including active oral infection, uncontrolled periodontitis, =2 non–radiotherapy-related oral ulcers, oral abscesses, or other conditions requiring dental intervention). 5. Upper respiratory tract infection within the past 2 weeks or antibiotics used during RT and follow-up. 6. History of head and neck radiation 7. Presence of cognitive impairment or inability to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHO Oral Mucositis (OM) Grading; | — |
Secondary
| Measure | Time frame |
|---|---|
| CTCAE score, RTOG classification, the number of days of painkiller/needle use during radiotherapy for patients, the number of days of intravenous nutrition use, gastrointestinal, hematological, hepatotoxicity and nephrotoxicity during radiotherapy, oral microbiota diversity (16S rRNA sequencing) and metabolomics characteristics (LC-MS non-targeted analysis);Late Radiation Toxicity Scoring Criteria (RTOG); | — |
Countries
China
Contacts
Public ContactLu Haijun
The Affiliated Hospital of Qingdao University
Outcome results
None listed