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Development and Validation of Prediction Model for Xerostomia Following Irradiation in Head and Neck Squamous Cell Carcinoma: A Prospective Study

Development and Validation of Prediction Model for Xerostomia Following Irradiation in Head and Neck Squamous Cell Carcinoma: A Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070010
Enrollment
Unknown
Registered
2023-03-31
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Interventions

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The primary tumor is HNSCC, with primary sites including the pharynx (including the nasopharynx, oropharynx, hypopharynx), larynx, and paranasal sinuses. Received curative radiotherapy. Able to tolerate MRI plain and enhanced examination (MRI plain and enhanced; cervical lymph node ultrasound) to determine the extent of primary lesion invasion and lymph node metastasis. The tumor has a clear pathological diagnosis and clinical stage is locally advanced (based on the AJCC 8th edition staging criteria for head and neck tumors: T1-4 N2-3 M0 but excluding nasopharyngeal carcinoma in stage T1-2 N1 M0, T3-4 N0-1 M0). Expected survival is more than 2 years. Allowed for lymph node metastasis in the neck and supraclavicular area. Allowed for induction chemotherapy, concurrent chemotherapy, consolidation chemotherapy, targeted therapy and other treatment methods to participate. Functional status score (KPS) >=70 points, physical status score (ECOG): 0-1 point. Age between 18-75 years old. Complete medical records (medical history, physical examination, relevant tests, previous treatment). Voluntary participation and signed informed consent form

Exclusion criteria

Exclusion criteria: Accept surgical treatment (excluding biopsy). History of other rheumatic immune system diseases, such as previous Sjogren's syndrome. Salivary gland surgery or other physical therapies. History of previous head and neck radiation therapy. History of previous head and neck surgery trauma. Refusal or inability to sign a written informed consent form.

Design outcomes

Primary

MeasureTime frame
xerostomia;Saliva flow rate;

Countries

China

Contacts

Public ContactPeiguo Wang

Tianjin Medical University Cancer Institute and Hospital

wpg2017@163.com+86 18622221196

Outcome results

None listed

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