Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Prolonged Nightly Fasting (PNF) on Immunotherapy Treatment Outcomes in Patients With Advanced Head and Neck Cancer (HNSCC)-Role of Gut Microbiome

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Prolonged Nightly Fasting
* Behavioral: Regular Eating pattern


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Exclusion Criteria: BMI< 18.5. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Prolonged Nightly Fasting<br>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. | Behavioral: Prolonged Nightly Fasting<br>* Limiting daily period of food intake to 10 hours and nightly fasting period to 14 hours.<br>* Other names: Intermittent Fasting;|
| Active Comparator: B: Regular Eating pattern<br>Participants will follow a traditional eating pattern with no time restrictions. | Behavioral: Regular Eating pattern<br>* Food intake not limited to a specific time during day/night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Prolonged Nightly Fasting (PNF) compliance | 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. | at 3 months | 
| Change in gut microbiome and microbial metabolites | 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. | Baseline and at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Fasting