MedTrace Logo

Efficacy of Superoxide Dismutase Spray in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .

NCT07400016 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-10

No results posted yet for this study

Summary

Radiotherapy always results in many complications such as radiation dermatitis,dry mouth, cranial nerve damage, and swallowing function. Among them,radiation dermatitis is confirmed to occur in the majority of tumor patientsreceiving radiotherapy, which not only affects the appearance but also causesthe interruption of radiotherapy in severe cases. At present, there is no standard treatment for radiation dermatitis. Superoxide dismutase (SOD) Spray is able to removefree radicals produced during radiotherapy, which may provide a new way andmethod for the prevention and treatment of radiation dermatitis. In addition,the product has obtained a safety assessment report from a third-party testingorganization, proving that it has fully met the applied human body standards. This clinical trial studies the effect of superoxide dismutase (SOD) Spray in preventing radiationdermatitis in Head and Neck Cancer.

Conditions

  • Radiation Dermatitis

Interventions

OTHER

Placebo Spray

Patients are instructed to apply the placebo spray to the treatment area twice daily, starting three days before radiotherapy (RT) and continuing until two weeks after treatment completion. The spray should be used to cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs.

OTHER

SOD spray

Patients are instructed to apply a thin layer of SOD spray to the treatment area twice daily, beginning three days before radiotherapy (RT) and continuing- Page 3 of 6 Arms Assigned Interventions until two weeks after treatment completion. The application should cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT to avoid potential buildup effects. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2027-01-31
Completion
2027-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400016 on ClinicalTrials.gov