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

NCT07400016 | Withdrawn

• 1 other identifier: HX2024-134-5
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence of grade 2 or higher radiation dermatitis.

  Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

Secondary Outcomes (7)

• The time to onset of grade 2 or higher radiation dermatitis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• The duration of grade 2 or higher radiation dermatitis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• The maximum skin toxicity.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• The Skindex-16 instrument.

  From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

• EORTC QLQ-C30.

  From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

Study Arms (2)

A placebo spray

PLACEBO COMPARATOR

A placebo spray containing excipients (lactose, potassium sorbate, and sorbitol) in addition to no SOD.

Other: Placebo Spray

Superoxide dismutase (SOD) Spray

EXPERIMENTAL

Other: SOD spray

Interventions

Placebo Spray OTHER

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.

A placebo spray

SOD spray OTHER

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.

Superoxide dismutase (SOD) Spray

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• \. Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy

You may not qualify if:

• \. Eastern Cooperative Oncology Group performance status of #2;
• Pre-existing skin rash, ulceration or open wound in the treatment area;
• \. Known allergy to trolamine or fullerene;
• \. Inflammatory or connectivetissue disorder of the skin;
• \. History of head and neck radiotherapy.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share