Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
NCT Number: NCT06484166
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Radiation Dermatitis
Interventions: OTHER: Fullerene cream|DRUG: Trolamine (Biafine)
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-04-30

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.

Primary Outcome Measures: 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: 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.