Head and Neck Squamous Cell CarcinomaPhase 1NCT05299203
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
A Phase 1 study testing Sapropterin dihydrochloride tablets in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Sapropterin dihydrochloride tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- May 2022to May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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)
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
- Being tested
- Sapropterin dihydrochloride tablets
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, radiation dermatitis, Sapropterin dihydrochloride, BH4
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapropterin dihydrochloride tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sapropterin dihydrochloride tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Subjects' quality of life is assessed according to the Spitzer Quality-of-Life Index (SQLI)
Measured: Assessment is performed two weeks before radiotherapy, the day at the end of radiotherapy, 2 weeks after radiotherapy, 4 weeks after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Ph.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299203
- Sponsor's protocol ID
- ChiCTR2100054693
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05299203
- Acronym / sponsor ID
- ChiCTR2100054693
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, radiation dermatitis, Sapropterin dihydrochloride, BH4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: Sapropterin dihydrochloride tabletsIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sapropterin dihydrochloride tabletsdose 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. | Drug | Dose Escalation and Expansion |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingchen Peng, Ph.D principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sapropterin dihydrochloride tablets in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng, Ph.D (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.