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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Phase Ia/Ib Clinical Trial of Sapropterin Dihydrochloride Tablets in the Prevention and Treatment of Radiation-induced Skin Reactions in Intensity Modulated Radiotherapy for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299203
• Other study ID #: ChiCTR2100054693
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2022
• Est. completion date: May 2023

Study information

• Verified date: March 2022
• Source: West China Hospital
• Contact: Xingchen Peng, Ph.D
• Phone: +8618980606753
• Email: pxx2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Nasopharyngeal Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Sapropterin dihydrochloride tablets
dose escalation phase (BH4) aqueous solution is sprayed onto the skin of all radiotherapy areas, 3 times a day until two weeks after the end of radiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dermatitis grading change from the baseline to the 4 weeks after radiotherapy	Radiation dermatitis is assessed according to the CTCAE 5.0 radiation dermatitis grading scale	Assessment is performed two weeks before radiotherapy, once a week during radiotherapy, the day at the end of radiotherapy, once a week for 4 weeks after radiotherapy.
Secondary	Subjects' quality of life score change from the baseline to the 4 weeks after radiotherapy	Subjects' quality of life is assessed according to the Spitzer Quality-of-Life Index (SQLI)	Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.