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Quantitative evaluation and prediction of xerostomia associated with radiotherapy and chemotherapy in patients with locally advanced head and neck squamous cell carcinoma by functional magnetic resonance imaging: a prospective study

Quantitative evaluation and prediction of xerostomia associated with radiotherapy and chemotherapy in patients with locally advanced head and neck squamous cell carcinoma by functional magnetic resonance imaging: a prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024328
Enrollment
Unknown
Registered
2019-07-06
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

xerostomia

Interventions

Gold Standard:Saliva Flow Rate measurement as well as patient-reported xerostomia score questionare.
magnetic&#32
resonance&#32
imaging&#32
of&#32
and&#32
neck.

Sponsors

Department of Radiation Oncology, the First Medical Center affiliated General Hospital of Chinese PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 The primary tumors were HNSCC, primary sites including pharynx (including nasopharynx, oropharynx, hypopharynx), larynx and etc. 2 Tumors were locally advanced (according to AJCC 8 Head and Neck Tumor Staging Criteria: T1-4N2-3M0 but not T1-2N1M0 nasopharyngeal carcinoma, T3-4N0-1M0); 3 Good performance status: ECOG 0-1; 4 Age ranges from 18 to 70 years old. 5 Expected survival was more than 2 years. 6 Complete medical records (medical history, physical examination, related examinations, past treatment); 7 Feasible MR plain scan + enhanced examination, salivary flow rate measurement and periodic dry mouth assessment scale score; 8 Imaging examination (plain and enhanced MRI; color Doppler ultrasound of superficial cervical lymph nodes) to determine the extent of invasion and lymph node metastasis of primary lesions; 9 Neck and supraclavicular lymph node metastasis is allowed. 10 Voluntary participation and written informed consent.

Exclusion criteria

Exclusion criteria: 1 Because of liver and kidney dysfunction, severe hematological toxicity and medical complications, induction chemotherapy and concurrent chemotherapy cannot be performed. 2 Other diseases of rheumatic immune system such as Sjogren's syndrome in the past; 3 Salivary gland surgery or other physiotherapy; 4 Trauma history of head and neck surgery in the past; 5 History of head and neck radiotherapy; 6 Surgical intervention was performed; 7 There are metal implants such as dentures and prostheses in the mouth; 8 Claustrophobia; 9 Recurrence or distant metastasis within 2 years after radiotherapy.

Design outcomes

Primary

MeasureTime frame
apparent diffusion coefficient;Ktrans;Mean kurtosis;saliva output flow rate;

Countries

China

Contacts

Public ContactLin Ma

Department of Radiation Oncology, the First Medical Center affiliated General Hospital of Chinese PLA

malinpharm@sina.com+86 010 66939297

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026