NCT06484166Completed
Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
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 patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases. At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards. This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 24 Jun 2024
- Start date
- Aug 2024
- Primary completion date
- Mar 2025
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06484166
What you commit to
- Study type: Interventional
- Participants enrolled: 132
- From Aug 2024 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to trolamine or fullerene;
- Inflammatory or connective tissue disorder of the skin;
- History of head and neck radiotherapy.
Other
- Eastern Cooperative Oncology Group performance status of \>2;
- Pre-existing skin rash, ulceration or open wound in the treatment area;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.