Clinical trial
Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Name
HX2024-134
Description
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.
Trial arms
Trial start
2024-07-15
Estimated PCD
2024-12-30
Trial end
2025-04-30
Status
Not yet recruiting
Treatment
Fullerene cream
Patients are instructed to apply a thin layer of the Fullerene cream third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.
Arms:
Fullerene cream
Trolamine (Biafine)
Patients are instructed to apply a thin layer of the Trolamine (Biafine) third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.
Arms:
Trolamine (Biafine)
Size
132
Primary endpoint
The incidence of grade 2 or higher radiation dermatitis.
From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}
Updated at
2024-07-02
1 organization
1 product
1 indication
Organization
West China HospitalProduct
TrolamineIndication
Radiation Dermatitis