Skin spray with superoxide dismutase to prevent radiation dermatitis in head and neck cancer
Official title: Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Run by West China Hospital · NCT07704372 · Data updated 2026-11-12
This study tests whether a topical superoxide dismutase spray can help prevent acute skin irritation in people with head and neck cancer undergoing radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | September 28, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07704372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with head and neck cancer planned for postoperative adjuvant or definitive radiotherapy, ECOG 0–2, and no active skin disease in the treatment area.
✕Probably not a fit
Those with pre-existing skin conditions in the treatment field, prior head and neck radiotherapy, or allergies to spray components may not benefit or could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 trial compares a topical SOD spray to a placebo in patients receiving radiotherapy for head and neck cancer. Participants will apply the spray to the treatment area to see if it reduces skin toxicity during therapy. The study will monitor safety and the severity of radiation dermatitis, with follow-up assessments during and after treatment. Eligibility includes adults with localized head and neck tumors, planned radiotherapy, and good performance status.
Why it matters
Potential benefit: If successful, participants may experience less severe skin reactions and better comfort during radiotherapy.
How similar studies have gone: Other antioxidant-based skin protectants have shown variable results; this approach is exploring a targeted SOD spray for dermatitis prevention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed malignant tumors of the head and neck without distant metastasis. 2. Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy. 3. Age 18-80 years at the time of consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Signed informed consent form. 6. Adequate cognitive and reading abilities to complete the questionnaire. Exclusion Criteria: 1. Pre-existing skin disease or open wounds in the irradiation field. 2. Have a history of head and neck radiotherapy. 3. Autoimmune or connective tissue disorders affecting skin. 4. Known allergy to any component of study formulations. 5. Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Where it's running
-
Sichuan University West China Hospital
Chengdu, Sichuan, China Recruiting
Study contacts
- Principal investigator: Xingchen Peng — Study Principal Investigator
- Study coordinator: Xingchen Peng
- Email: pxx2014@163.com
- Phone: +86 18980606753
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.