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A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05114226
Recruitment Status : Not yet recruiting
First Posted : November 9, 2021
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Rutie Yin, West China Second University Hospital

Brief Summary:
This study was a single-center prospective phase I clinical study to evaluate the effectiveness and safety of BH4 in the treatment of radiation-induced skin injury during vulvar cancer radiotherapy.

Condition or disease Intervention/treatment Phase
Radiation-Induced Dermatitis Drug: Tetrahydrobiopterin Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

The degree of the skin injury during the radiotherapy was assessedaccording to the radiation morbidity scoring criteria of the Radiation Therapy Oncology Group (RTOG).After the start of radiotherapy, the degree of the damage to the patient's skin was assessed every week. BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

BH4 gradient: 50, 100, 200, 400, 600, 800, and 1,000 ug/ml.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Professor
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group (BH4 solvent 50 ug/ml)
A sterile gauze was soaked with BH4 solvent (50 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group (BH4 solvent 100 ug/ml)
A sterile gauze was soaked with BH4 solvent (100 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group(BH4 solvent 200 ug/ml)
A sterile gauze was soaked with BH4 solvent (200 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group(BH4 solvent 400 ug/ml)
A sterile gauze was soaked with BH4 solvent (400 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group(BH4 solvent 600 ug/ml)
A sterile gauze was soaked with BH4 solvent (600 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group(BH4 solvent 800 ug/ml)
A sterile gauze was soaked with BH4 solvent (800 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.

Experimental: experimental group(BH4 solvent 1000 ug/ml)
A sterile gauze was soaked with BH4 solvent (1000 ug/ml), wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.
Drug: Tetrahydrobiopterin
BH4 was applied when skin damage≥ Grade I occurred. A sterile gauze was soaked with BH4 solvent, wringed out, and applied to the treated skin area for 15 minutes. It was applied three times a day (morning, noon, and evening), until three months after the end of treatment.




Primary Outcome Measures :
  1. Acute radiation dermatitis incidence [ Time Frame: up to 12 weeks ]
    incidence that was evaluated every week (according to RTOG radiation morbidity scoring criteria)


Secondary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: up to 5 years ]
    Follow-up until the death of the patient or withdraw from the clinical study

  2. overall survival (OS) [ Time Frame: up to 5 years ]
    Follow-up until the death of the patient or withdraw from the clinical study

  3. cancer remission rate assessed by imaging [ Time Frame: up to 12 weeks ]
    It was evaluated one month and three months after the end of treatment


Other Outcome Measures:
  1. adverse events [ Time Frame: up to 12 weeks ]
    Follow-up until the death of the patient or withdraw from the clinical study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 18years old female patients.
  2. The subjects of the study were pathologically diagnosed vulvar cancer patients, who needed postoperative supplemental radiotherapy, patients who received radical radiotherapy and chemotherapy (unresectable locally advanced tumors, including some stage II with tumor diameter > 4 cm or tumor invading vagina, urethra, and anus), and early-stage patients with possible serious postoperative complications or serious complications, where in the option of undergoing a surgery was not appropriate.
  3. The Eastern Cooperative Oncology GroupPerformance Status (ECOG PS) score: 0-1.
  4. Expected survival ≥12 months.
  5. The main organs functioned normally, which meant that they met the following criteria:

1) Blood routine examination results:

  • Hemoglobin (Hb) ≥90g/L. ② Absolute neutrophil count (ANC)≥1.5×109/L. ③ Platelet count (PLT) ≥50×109/L. 2) Biochemical examination results:
  • Total bilirubin (TBIL)<1.5×upper limit of normal (ULN).

    • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5×ULN,for patients with liver metastasis<5×ULN.

      ③ Blood urea nitrogen (BUN) and Creatinine ratio (CR) ≤1×ULN or Endogenous creatinine clearance≥50ml/min(by Cockcroft-Gault equation).

      6. The subjects willingly participated inthe study, signed an informed consent form, were medication-compliant, and cooperated with the follow-ups.

Exclusion Criteria:

  1. Patients with hypertension and could not control the blood pressure within the normal range after treating with antihypertensive medications (systolic blood pressure>140 mmHg and diastolic blood pressure>90 mmHg).
  2. Patients with a history of severe cardiovascular diseases, including myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (QTc interval ≥470 ms in women), grade III~IV cardiac insufficiencyaccording to the New York Heart Association (NYHA) standards, orthe left ventricular ejection fraction (LVEF) < 50%shown by the heart color Doppler ultrasound.
  3. Patients with coagulation disorders (international normalized ratio (INR) >1.5, activated partial thromboplastin time (aPTT) >1.5 ULN), with bleeding tendency.
  4. Patients with a history of psychotropic medication abuse and unable to quit, and patients with mental disorders.
  5. Patients participatingin another drug trial.
  6. Patients with concomitant diseases that seriously endangered the safety of the patient or affected the completion of the study from the investigators' opinion.
  7. Not suitable for enrollment in the investigators' opinion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05114226


Locations
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China, Sichuan
est China Second Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Second University Hospital
Publications of Results:
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Responsible Party: Rutie Yin, Clinical Professor, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT05114226    
Other Study ID Numbers: WCSUH2021002
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rutie Yin, West China Second University Hospital:
Tetrahydrobiopterin
Radiation-Induced Skin Injury
Phase I Clinical Study
Vulvar Cancer
Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries