Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The incidence of grade 2 or higher radiation dermatitis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- •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.
排除标准
- •Eastern Cooperative Oncology Group performance status of >2;
- •Pre-existing skin rash, ulceration or open wound in the treatment area;
- •Known allergy to trolamine or fullerene;
- •Inflammatory or connective tissue disorder of the skin;
- •History of head and neck radiotherapy.
研究组 & 干预措施
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.
干预措施: Trolamine (Biafine) (Drug)
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.
干预措施: Fullerene cream (Other)
结局指标
主要结局
The incidence of grade 2 or higher radiation dermatitis.
时间窗: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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.
次要结局
- EORTC QLQ-H&N35(From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.)
- The time to onset of grade 2 or higher radiation dermatitis.(From the start of radiotherapy to 4 weeks after completion of radiotherapy.)
- The Skindex-16 instrument.(From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.)
- Adverse events.(From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.)
- The duration of grade 2 or higher radiation dermatitis.(From the start of radiotherapy to 4 weeks after completion of radiotherapy.)
- The maximum skin toxicity.(From the start of radiotherapy to 4 weeks after completion of radiotherapy.)
- EORTC QLQ-C30.(From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital