Phase IV Study on the Feasibility of a Preventative/Therapeutic Approach With Benzydamine Oromucosal Solution in Radiation-induced Oral Mucositis (OM) in Patients With Head and Neck Cancer (HNC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Number of responders
研究概览
简要总结
The aim of the present study is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with head and neck cancer.
详细描述
This is a phase IV clinical study whose aim is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with Head and Neck cancer.
Benzydamine mouthwash is considered the gold standard among anti-inflammatory agents in the management of oral mucositis in cancer patients.
The 2014 mucositis guidelines recommended benzydamine mouthwash for the prevention of radiation-induced oral mucositis among Head and Neck Cancer patients treated with moderate doses of radiation therapy. The updated 2019 guidelines not only confirm the existing guidelines proving new evidences, but also recommend to use benzydamine as preventative treatment of radiation-induced Oromucositi among Head and Neck Cancer. patients treated with radiation therapy with/without systemic concurrent treatments and confirm benzydamine mouthwash as the only anti-inflammatory agent with evidence in prevention of oral mucositis to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of any ethnic origin ≥18 years of age.
- •Patients diagnosed with stage III or IV Head and Neck cancer (histologic or cytologic diagnosis), according to VIII AJCC staging system, who are candidate and are about to start RT, with or without concomitant CT, with curative intent, either with exclusive or postoperative intent.
- •Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or
- •Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent and the Declaration of consent for the processing of personal data.
- •Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the end of the study, using an appropriate birth control method, such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- •Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
排除标准
- •Patients with reported allergy to benzydamine or another component of the formulation used.
- •Any contraindications listed in the local product's Summary of Product Characteristics (SmPCs).
- •Patients with prior head and neck RT (in the previous 6 months), or patient who received a palliative treatment.
- •Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions.
- •Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.).
- •Patients who use other oromucosal products (over the counter or prescription) for the same disease.
- •Prescription of other rinses (anaesthetics like "magic mouthwashes" or others), except from sodium bicarbonate rinses.
- •Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol, granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel.
- •Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; any therapeutic use in case of overt clinical infections is allowed.
- •Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition.
- •Patients treated with any topical anti-inflammatory/analgesic products for the mucositis.
- •Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator's assessment.
研究组 & 干预措施
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A., is assigned to the patients for radiation-induced oromucositis.
The patients take at home 15 ml (1 tablespoon) of concentrated or diluted (with water) mouthwash 2-3 times a day, but not more than 5 times a day, washing the mouth and throat for 20-30 seconds, according to the Investigator's indications and the local product's SmPC.
In Hungary, the therapy should started with diluted product (15 ml of water + 15 ml of concentrated solution). After that, gargling can be continued with 15 ml (1 tablespoon) of concentrated mouthwash, generally 2-3 times a day, but not more than 5 times a day.
In Poland, the solution is used 2 to 3 times daily; at a single time, it should be used approximately 15 ml of concentrated or diluted mouthwash with a small amount of water and wash the mouth and throat for 20 to 30 seconds.
干预措施: Benzydamine Hydrochloride 0.15% w/v oromucosal solution (Drug)
结局指标
主要结局
Number of responders
时间窗: Up to 7 weeks
The effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/tratment of radiation-induced oral mucositis in Head and Neck cancer patients is evaluated as the number of responders, expressed in percentage, defined as the number of head and neck cancer patients with oral mucositis pain intensity \<5 in the Numeric Rating Scale.
次要结局
- Change score in the World Health Organization oral mucositis grading scale.(Up to 7 weeks)
- Change in QoL (EORTC QLQ-H&N35) from baseline(Up to 7 weeks)
- Time of onset of severe oral mucositis.(Up to 7 weeks)
- Number of days of discontinuation of Radiotherapy/Chemotherapy(Up to 7 weeks)
- Delays in Radiotherapy/Chemotherapy(Up to 7 weeks)
- Frequency of adverse events(Up to 7 weeks)
- Number of compliant patients to Benzydamine treatment.(Up to 7 weeks)
- Number of days of duration of severe oral mucositis.(Up to 7 weeks)
- Dose modifications of Radiotherapy/Chemotherapy(Up to 7 weeks)
- Percentage change in body weight(Up to 7 weeks)
- Number of days of duration of Radiotherapy/Chemotherapy(Up to 7 weeks)
- Number of days of hospitalization.(Up to 7 weeks)
- Change in QoL (EORTC QLQ C-30) from baseline(Up to 7 weeks)
- Number and type of opioid analgesics(Up to 7 weeks)