Clinical trial NCT06484166: Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Official title: Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Detailed description: Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Complications such as radiation dermatitis, dry mouth, cranial nerve damage, and poor swallowing function can occur in patients with head and neck cancer undergoing radiotherapy. Data from previous retrospective studies have shown that up to 90% of patients with head and neck tumors will develop radiation dermatitis after radiotherapy. Radiation dermatitis may cause the radiotherapy interrupted and treatment time prolonged, which will ultimately affect the treatment outcome and overall quality of life.

At present, there is no standard treatment for radiation dermatitis. Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. In China, Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity.

Fullerene is hollow molecules made entirely of carbon, with the ability to remove free radicals produced during radiotherapy. At the same time, Fullerene cream contains active ingredients such as ecdoine and sodium hyaluronate, which can effectively promote collagen production and speed up the repair of damaged skin. 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.

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.

Primary outcomes:
measure: The incidence of grade 2 or higher radiation dermatitis.
timeFrame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Secondary outcomes:
measure: The time to onset of grade 2 or higher radiation dermatitis.
timeFrame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
measure: The duration of grade 2 or higher radiation dermatitis.
timeFrame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
measure: The maximum skin toxicity.
timeFrame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
measure: The Skindex-16 instrument.
timeFrame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
measure: EORTC QLQ-C30.
timeFrame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
measure: EORTC QLQ-H&N35
timeFrame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
measure: Adverse events.
timeFrame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xingchen Peng
role: PRINCIPAL_INVESTIGATOR
References: