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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Behavioral: Regular Eating pattern; Behavioral: Prolonged Nightly Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT05083416

MCC-21150

20121102 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

A: Prolonged Nightly Fasting

Experimental group

Description:

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.

Treatment:

Behavioral: Prolonged Nightly Fasting

B: Regular Eating pattern

Active Comparator group

Description:

Participants will follow a traditional eating pattern with no time restrictions.

Treatment:

Behavioral: Regular Eating pattern