Head and Neck Cancer
Conditions
Keywords
Intermittent Fasting
Brief summary
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.
Interventions
BEHAVIORALProlonged Nightly Fasting
Limiting daily period of food intake to 10 hours and nightly fasting period to 14 hours.
BEHAVIORALRegular Eating pattern
Food intake not limited to a specific time during day/night.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
American Cancer Society, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Prolonged Nightly Fasting (PNF) compliance | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Chung, MD
Moffitt Cancer Center
Outcome results
None listed