Clinical trial · Interventional
Efficacy of Fullerene 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
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 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.
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 |
|---|---|---|---|
| Fullerene cream | Other | — | UNRESOLVED |
| Trolamine (Biafine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Trolamine (Biafine)
- description
- Trolamine (Biafine; Genmedix Ltd, France) is cream packed in an opaque white bottle of 50g each, which is the same as the experimental group in appearance.
- interventionNames
- Drug: Trolamine (Biafine)
- type
- EXPERIMENTAL
- label
- Fullerene cream
- description
- Fullerene cream is cream packed in an opaque white bottle of 50g each, which is the same as the control group in appearance.
- interventionNames
- Other: Fullerene cream
Primary outcomes (1)
- measure
- The incidence of grade 2 or higher radiation dermatitis.
- timeFrame
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 connective tissue disorder of the skin; 5. History of head and neck radiotherapy.
References
Publications (1)
- DERIVEDLiu Z, Liu X, Li Z, Xie J, Gao K, Pei Y, Gu Z, Peng X. Fullerene for Reducing Acute Radiation Dermatitis in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Phase II, Double-Blind, Randomized Controlled Trial. J Clin Oncol. 2026 May;44(13):1206-1215. doi: 10.1200/JCO-25-02264. Epub 2026 Mar 20. PMID 41861269