Efficacy and Cost Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Locally Advanced Head and Neck Cancer to Prevent Aspiration Pneumonia. A Randomized Phase II-III Study
试验速览
- 阶段
- 2 期
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- the number of definite pneumonia and/ or suspected pneumonia
研究概览
简要总结
Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life.
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
详细描述
Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer (LAHNC). It will be administered to patients for unresectable disease or for organ preservation as primary treatment. Furthermore, it can be used as postoperative treatment in case high risk recurrent disease is present. This treatment induces a high rate of acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with an immense impact on Quality of life (QoL).
Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.
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
- 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
- •Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- •Written informed consent
- •Expected adequacy of follow-up
排除标准
- •Patients with pneumonia within the last 14 days before start of CRT
- •Patients with other infections within the last 14 days within the last 14 days before start of CRT
- •Patients with use of maintenance antibiotics
- •Patients with antibiotic treatment within the last 14 days before start of CRT
- •Patients with an allergy on amoxicillin
研究组 & 干预措施
prophylactic treatment
Administration of prophylactic amoxicillin/clavulanic acid suspension, 625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT. If a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics)
干预措施: amoxicillin/clavulanic acid suspension (Drug)
结局指标
主要结局
the number of definite pneumonia and/ or suspected pneumonia
时间窗: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Definite pneumonia: Evidence of pneumonia on chest radiography or 3 or more of the following: Sustained fever (temperature\> 100 f \[38°C\]), Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen Suspected pneumonia: At least 2 of the 4 following features are present, without evidence of pneumonia on chest radiography: Sustained fever (temperature\> 100 f \[38°C\]) Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen
次要结局
- effects on Quality of Life(Baseline, Day 28 last day of CRT, 3,5 months after CRT)
- Number and kind of positive blood cultures(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- number of admissions to hospital(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- Number of days of admission(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- Effects on mortality(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- effects on mucositis: grade and duration(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- side effects of amoxicillin/clavulanic acid(from day 1 of 1 CRT until 3,5 mnd after the last CRT)
- Effects on numbers and causative agents of infections at other sites(during follow up)