Clinical trial · Interventional
Efficacy of Superoxide Dismutase Spray in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was withdrawn prior to enrollment due to administrative error in the registration process, specifically an incorrect ethics approval number was recorded. A corrected version of the study has been re-registered under a new record.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Spray | Other | — | UNRESOLVED |
| SOD spray | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- A placebo spray
- description
- A placebo spray containing excipients (lactose, potassium sorbate, and sorbitol) in addition to no SOD.
- interventionNames
- Other: Placebo Spray
- type
- EXPERIMENTAL
- label
- Superoxide dismutase (SOD) Spray
- interventionNames
- Other: SOD spray
Primary outcomes (1)
- measure
- The incidence of grade 2 or higher radiation dermatitis.
- timeFrame
- From the start of radiotherapy to 4 weeks after completion of radiotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; * 2\. 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 Exclusion Criteria: * 1\. Eastern Cooperative Oncology Group performance status of #2; * 2.Pre-existing skin rash, ulceration or open wound in the treatment area; * 3\. Known allergy to trolamine or fullerene; * 4\. Inflammatory or connectivetissue disorder of the skin; * 5\. History of head and neck radiotherapy.
References
Publications (0)
Data not yet available