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Clinical study on the effect of nutrition management on radiation oral mucositis in advanced head and neck tumors

A prospective one-arm cohort study of the effect of periradiotherapy nutrition management on radiation oral mucositis in patients with advanced head and neck tumors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067866
Enrollment
Unknown
Registered
2023-01-29
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

head and neck neoplasm

Interventions

Nutrition management group:Periradiotherapy nutrition management based on standard anti-tumor therapy
Standard anti-tumor treatment group:N/A

Sponsors

Drum Tower Hospital Affiliated to Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Definite diagnosis of advanced head and neck cancer (III-IV inoperable); 3. Predicted survival time > 3 months; 4. Radical radiotherapy combined with chemotherapy or immunotherapy in our hospital; 5. The patient was conscious and had no communication disorder; 6. Informed consent, voluntary participation in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with previous surgery or radiotherapy for head and neck cancer; 2. Patients with concurrent or previous history of other tumors; 3. Distant metastasis; 4. Patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition; 5. Severe renal insufficiency (eGFR < 30 ml/min/1.73m2); 6. Combined with poorly controlled metabolic diseases such as diabetes; 7. Doctors or researchers deem that they are not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Degree of radiotherapy-induced oral mucositis (RIOM) (Radiation Therapy Oncology Group (RTOG) toxicity);

Secondary

MeasureTime frame
Nutrition Serum indicators;Body composition Measures;Nutrition assessment indicators;Inflammatory metabolic indicators: IL-6, hs-CRP;

Countries

China

Contacts

Public ContactJing Yan

Drum Tower Hospital Affiliated to Medical School of Nanjing University

yanjing@njglyy.com+86 15805182426

Outcome results

None listed

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