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RecruitingPhase 2NCT07545720

Pinoxin for the Prevention of Radiation-Induced Skin Injury

A Multicenter, Randomized, Controlled, Double-Blind Clinical Study of Hydrogen-Donor Modified SOD (Pinoxin) for the Prevention of Radiation-Induced Skin Injury

Sponsor

Fudan University

Enrollment

202 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Cancer Patients Undergoning Radiotherapy

Summary

The incidence of radiation-induced skin injury is high, and effective preventive measures are currently lacking. This study evaluates the role of the skin protective agent Pinoxin in preventing skin injury. Patients are randomly assigned into two prospective groups: treatment group and control group. In treatment group, patients will receive Pinoxin treatment. In control group，patients will receive placebo treatment. The rate of grade 2 or greater skin injury will be analyzed.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥ 18 years, regardless of gender.
  • Pathologically diagnosed with a malignant tumor.
  • Scheduled to receive long-course radiotherapy with a total dose of ≥50 Gy, in accordance with standard treatment guidelines.
  • No prior history of radiotherapy.
  • Has provided signed and dated informed consent, indicating that the patient has been informed of all relevant aspects of the study.
  • Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria7

  • History of dermatologic conditions (e.g., vitiligo, psoriasis, etc.) or collagen vascular diseases.
  • Planned hypofractionated radiotherapy regimen.
  • Recent use (e.g., within 3 months) of similar topical protective agents.
  • Known hypersensitivity to any related components or materials.
  • Immunodeficiency disorders.
  • Women who are pregnant or lactating.
  • Any other condition that, in the investigator's judgment, may compromise patient safety or protocol compliance. This includes severe concomitant illnesses (including psychiatric disorders) requiring active treatment, significant laboratory abnormalities, or significant social/familial factors.

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Interventions

DRUGpinoxin

Treatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent.

DRUGPlacebo

Treatment group will receive prophylactic skin administration of placebo

Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07545720