Efficacy of Superoxide Dismutase Spray in Preventing Radiation Dermatitis in Patients With Head a… (NCT07400016) | Clinical Trial Compass
WithdrawnNot Applicable
Efficacy of Superoxide Dismutase Spray in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Stopped: This study was withdrawn prior to enrollment due to administrative error in the registration process, specifically an incorrect ethics approval number was recorded.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.
0Started 2026-02-10
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of grade 2 or higher radiation dermatitis.
Timeframe: From the start of radiotherapy to 4 weeks after completion of radiotherapy