Effect of Prolonged Nightly Fasting (PNF) on Immunotherapy Treatment Outcomes in Patients With Advanced Head and Neck Cancer (HNSCC)-Role of Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Rates of Prolonged Nightly Fasting (PNF) compliance
研究概览
简要总结
This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Newly diagnosed recurrent /metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
排除标准
- •BMI< 18.
- •Diabetes mellitus, hyperthyroidism, pregnancy, any eating disorder including anorexia nervosa or bulimia, metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.
研究组 & 干预措施
B: Regular Eating pattern
Participants will follow a traditional eating pattern with no time restrictions.
干预措施: Regular Eating pattern (Behavioral)
A: Prolonged Nightly Fasting
Participants will be educated on Prolonged Nightly Fasting (PNF) and the "mycircadianapp". Participants be allowed to choose any 10-hr period that falls between 6 AM- 6 PM, as feeding period. Participants will be recommended to follow study diet guidelines, eat to satiety and not count calories. Participants will be allowed to have water, beverages (<4 kcal) during the fasting period.
干预措施: Prolonged Nightly Fasting (Behavioral)
结局指标
主要结局
Rates of Prolonged Nightly Fasting (PNF) compliance
时间窗: at 3 months
Adherence to the 8-10 hour time restricted feeding window will be measured using "mycircadianclock" app ,which has been validated as a tool to conveniently and reliably track time of food intake and its correlation with timing of the day and sleep. It can be tailored to restrict feeding duration to specific set points.
Change in gut microbiome and microbial metabolites
时间窗: Baseline and at 12 weeks
Changes in gut microbiome composition/diversity as well as gut microbial metabolites in participants using PNF will be compared with participants that are not restricting eating times will be measured using stool samples.
次要结局
未报告次要终点