Back to resultsBH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sapropterin dihydrochloride tablets
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Squamous Cell Carcinoma focused on measuring head and neck squamous cell carcinoma, nasopharyngeal carcinoma, radiation dermatitis, Sapropterin dihydrochloride, BH4
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation and Expansion
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05299203
Brief Title
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
head and neck squamous cell carcinoma, nasopharyngeal carcinoma, radiation dermatitis, Sapropterin dihydrochloride, BH4
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation and Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sapropterin dihydrochloride tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiation dermatitis grading change from the baseline to the 4 weeks after radiotherapy
Description
Radiation dermatitis is assessed according to the CTCAE 5.0 radiation dermatitis grading scale
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.
Secondary Outcome Measure Information:
Title
Subjects' quality of life score change from the baseline to the 4 weeks after radiotherapy
Description
Subjects' quality of life is assessed according to the Spitzer Quality-of-Life Index (SQLI)
Time Frame
Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingchen Peng, Ph.D
Phone
+8618980606753
Email
pxx2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng, Ph.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
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