NCT05083416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2024

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

October 4, 2021

Last Update Submit

February 5, 2026

Conditions

Head and Neck Cancer

Keywords

Intermittent Fasting

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

A: Prolonged Nightly Fasting

EXPERIMENTAL

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

B: Regular Eating pattern

ACTIVE COMPARATOR

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

Behavioral: Regular Eating pattern

Interventions

Prolonged Nightly FastingBEHAVIORAL

Limiting daily period of food intake to 10 hours and nightly fasting period to 14 hours.

Also known as: Intermittent Fasting
A: Prolonged Nightly Fasting
Regular Eating patternBEHAVIORAL

Food intake not limited to a specific time during day/night.

B: Regular Eating pattern

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsIntermittent Fasting

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsFastingFeeding BehaviorBehavior

Study Officials

  • Christine Chung, MD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 19, 2021

Study Start

October 20, 2021

Primary Completion

March 31, 2023

Study Completion

February 8, 2024

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)