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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Prolonged Nightly Fasting; Behavioral: Regular Eating pattern

• Registration Number: NCT05083416
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2021-10-20
• Primary Completion: 2023-03-31
• Study Completion: 2024-02-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Prolonged Nightly Fasting	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.
B: Regular Eating pattern	Regular Eating pattern	Participants will follow a traditional eating pattern with no time restrictions.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States