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

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Dose Escalation and Expansion
    • In the dose escalation phase, 9 patients will be included in 3 groups with 3 patients as one group. In the dose expansion phase, the concentration of Sapropterin dihydrochloride tablets (BH4) aqueous solution will be performed according to the effective concentration of dose escalation phase, and 9 patients will be enrolled.

Clinical Trial Outcome Measures

Primary Measures

  • Radiation dermatitis grading change from the baseline to the 4 weeks after radiotherapy
    • Time Frame: 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.
    • Radiation dermatitis is assessed according to the CTCAE 5.0 radiation dermatitis grading scale

Secondary Measures

  • Subjects’ quality of life score change from the baseline to the 4 weeks after radiotherapy
    • Time Frame: Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.
    • Subjects’ quality of life is assessed according to the Spitzer Quality-of-Life Index (SQLI)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West China Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xingchen Peng, PhD, Professor – West China Hospital
  • Overall Official(s)
    • Xingchen Peng, Ph.D, Principal Investigator, West China Hospital
  • Overall Contact(s)
    • Xingchen Peng, Ph.D, +8618980606753, pxx2014@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.