Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .

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.

Study Overview

• Status: Completed
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Drug: Trolamine (Biafine); Other: Fullerene cream

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 646000
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trolamine (Biafine); 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.	Drug: 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.
Experimental: Fullerene cream; Fullerene cream is cream packed in an opaque white bottle of 50g each, which is the same as the control group in appearance.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of grade 2 or higher radiation dermatitis.	Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.	From the start of radiotherapy to 4 weeks after completion of radiotherapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to onset of grade 2 or higher radiation dermatitis.	Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.	From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The duration of grade 2 or higher radiation dermatitis.	The first determination of grade 2 or higher radiation dermatitis to the first instance of grade 1 or 0 radiation dermatitis, without a subsequent instance of grade 2 or higher radiation dermatitis. Patients without observed grade 2 or higher radiation dermatitis were assigned a duration of 0 days.	From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The maximum skin toxicity.	The maximum grade of RTOG skin toxicity between 0 and 4.	From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The Skindex-16 instrument.	The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the QoL of patients. Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with acne. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-C30.	The EORTC QLQ-C30 consists of five functional scales, nine symptom scales and one global quality of life (QoL) scale, and has been validated in an international setting.The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100；or functional scales, high scores represent a high level of QoL，and for symptom scales high scores indicate a poor QoL.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-H&N35	The EORTC QLQ-H&N35 covers issues specific to HNC patients and includes 18 symptom scales; it has been validated in an international setting and is used extensively in HRQoL research. The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100；or functional scales, high scores represent a high level of QoL，and for symptom scales high scores indicate a poor QoL.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Adverse events.	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Xingchen Peng, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 31, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Skin Diseases; Radiation Injuries; Head and Neck Neoplasms; Dermatitis; Radiodermatitis; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Biafine
• Other Study ID Numbers: HX2024-134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No