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

NCT05299203 | Unknown Phase 1

• 1 other identifier: ChiCTR2100054693
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; nasopharyngeal carcinoma; radiation dermatitis; Sapropterin dihydrochloride; BH4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjects' quality of life score change from the baseline to the 4 weeks after radiotherapy

  Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.

Study Arms (1)

Dose Escalation and Expansion

EXPERIMENTAL

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.

Drug: Sapropterin dihydrochloride tablets

Interventions

Sapropterin dihydrochloride tablets DRUG

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.

Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Radiodermatitis

Interventions

sapropterin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Xingchen Peng, Ph.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng, Ph.D

CONTACT

+8618980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 28, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03