Status:
UNKNOWN
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
Lead Sponsor:
West China Hospital
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Head and neck squamous cell carcinoma (include nasopharyngeal carcinoma) is one of the most common malignant tumor in China, and radiotherapy is the main treatment method. Radiation-induced dermatitis...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
- Age ≥ 18 years old, ≤ 80 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using intensity modulated radiotherapy.
- Blood routine examination: hemoglobin ≥ 100g/L, platelet count ≥ 75×10\^9/L, white blood cell count ≥ 3.0×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L. Blood biochemistry: total bilirubin≤1.5 upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, serum creatinine ≤1.5 ULN or creatinine clearance rate \>=60ml/min.
- Have signed informed consent form.
Exclusion
- Allergic to the components of Sapropterin dihydrochloride tablets or severe allergic constitution.
- Poor compliance.
- Pregnant or breastfeeding.
- Any previous radiotherapy to the head and neck region.
- Patients deemed unsuitable for the study by the investigator (concomitant with any other serious disease)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05299203
Start Date
May 1 2022
End Date
May 1 2023
Last Update
March 28 2022
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