Overview

BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
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 is one of the most common complications of head and neck squamous cell carcinoma patients during radiotherapy. Severe radiation dermatitis will cause secondary infection, severe pain, and even lead to the interruption of radiotherapy. On the one hand, it will affect the efficacy of tumor treatment, which may affect the long-term survival of patients, and on the other hand, it will also seriously affect the quality of life of patients. Tetrahydrobiopterin(BH4), also known as sapropterin, has been shown not only to reduce the severity of acute radiation dermatitis but also to enhance the repair of skin injury in animal experiments. It may be a new approach and method for the prevention and treatment of radiation-induced dermatitis
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Treatments:
Verapamil
Criteria
Inclusion Criteria:

1. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including
nasopharyngeal carcinoma).

2. Age ≥ 18 years old, ≤ 80 years old.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

4. Head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using
intensity modulated radiotherapy.

5. 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.

6. Have signed informed consent form.

Exclusion Criteria:

1. Allergic to the components of Sapropterin dihydrochloride tablets or severe allergic
constitution.

2. Poor compliance.

3. Pregnant or breastfeeding.

4. Any previous radiotherapy to the head and neck region.

5. Patients deemed unsuitable for the study by the investigator (concomitant with any
other serious disease)