A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck (SCCHN) With a Dietary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 11
- 主要终点
- Reduction in the incidence of tumor recurrence and second primaries
研究概览
简要总结
This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.
详细描述
Patients deemed to be in complete remission at month 3 (+/- 1 month) after curative treatment will be considered for this trial.
At each follow up visit the patients will state all the changes and new symptoms they experienced and they will receive both physical and fiberoptic endoscopic head and neck examination. Locoregional imaging should preferentially be performed within 6 months after treatment end and then will be recommended only on the occurrence of new signs or symptoms. Late adverse events of the treatment will be evaluated at each visit according to Common Toxicity Criteria of Adverse Events (CTCAE version 4.0). Quality of life questionnaire (EORTC QLQ HN35) and VSAQ questionnaire will be administered to patients every other visit. Laboratory tests including a complete blood count, renal, hepatic and thyroid function will be performed once a year. The analysis of blood biomarkers of compliance and efficacy will be conducted at baseline, 3, 6, 12, 18 and 24 months after randomization.
The proposed study foresees two arms of intervention: the experimental arm based on dietary intervention in addition to standard recommendations and a control arm which includes only standard recommendations.
The intervention strategy will focus on reducing inflammation and reducing glycaemia and insulinaemia while promoting nutrient-rich diet.
Patients will be taught how to prepare traditional Mediterranean meals (healthy, satiating, palatable and easy to prepare).
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
- 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
- •High-risk effectively cured stage III and IV HNSCC
- •Oropharyngeal cancer will be enrolled only if with a smoking history of more than 10 pack/years
- •Able to swallow at least a soft pureed diet
- •Male or female > 18 years
- •Signed written informed consent
排除标准
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- •Non parotid-sparing RT
- •Severely malnourished patients (patients with a weight loss greater that 5% in the last month before enrollment and with a BMI < 20)
- •Diabetic patients in pharmacological treatment
- •Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study
- •Other significant disease that in the investigator's opinion would exclude the subject from the trial
- •Patients unable to comply with the protocol, in the opinion of the investigator
结局指标
主要结局
Reduction in the incidence of tumor recurrence and second primaries
时间窗: 36 months
Reduction in the incidence of tumor recurrence and second primaries will be assessed. When a clinical or radiological evidence of recurrence exists, all the efforts should be made in order to perform a histological confirmation. It is possible that a certain amount of recurrences will not be cyto/histologically confirmed due to tumor location not making the sampling feasible. It will be accepted a maximum percentage of 10% of such cases, if in presence of at least 2 different concordant radiological imaging.
Identification of saliva and plasma miRNAs and evaluation of their change in the 2 arms of treatment
时间窗: 36 months
The project involves the monitoring of miRNAs during the dietary intervention to ascertain the effectiveness of the treatment and the relationship with clinical outcome
Change in inflammatory cytokine profile during the course of dietary intervention
时间窗: 36 months
The change in inflammatory cytokine profile during the course of dietary intervention and the comparison with control arm will be evaluated
次要结局
- EORTC HN35 quality of life scales(36 months)
- Reduction of treatment related side effects(36 months)
- Identification of cytokine and growth factors(36 months)
- Monitoring of DNA methylation(36 months)