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

March 17, 2022 updated by: Xingchen Peng, West China Hospital

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: XingChen Peng, Ph.D
  • Phone Number: +8618980606753
  • Email: pxx2014@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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)
Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: XingChen Peng, Ph.D, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR2100054693

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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