Self Healing Gel as a Vehicle for Recombinant Human Epidermal Growth Factor in Treatment of Oral Mucositis Following Cancer Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 主要终点
- The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
研究概览
简要总结
Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Containers supplied for groups I and II will be identical and will be supplied by a third party pharmacist not a member of this study to ensure participant and patient blinding.
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
- 否
入选标准
- •Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.
排除标准
- •Patients with hematologic malignancies or those with known allergic reactions to the drug.
研究组 & 干预措施
EGF loaded Hydrogel (Gp I)
30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks.
干预措施: EGF loaded Hydrogel (Drug)
Hydrogel alone ( Gp II)
30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks.
干预措施: Hydrogel (Drug)
结局指标
主要结局
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
时间窗: After 14 days of treatment.
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
WHO grade of mucositis
时间窗: After 14 days of treatment.
Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible
次要结局
未报告次要终点
研究者
Basma Elsaadany
Lecturer of oral medicine and periodontology
Cairo University