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

NCT ID: NCT05083416

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2024-02-08

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.

Detailed Description

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Conditions

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Head and Neck Cancer

Keywords

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Intermittent Fasting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A: 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.

Group Type EXPERIMENTAL

Prolonged Nightly Fasting

Intervention Type BEHAVIORAL

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

B: Regular Eating pattern

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

Group Type ACTIVE_COMPARATOR

Regular Eating pattern

Intervention Type BEHAVIORAL

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

Interventions

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Prolonged Nightly Fasting

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

Intervention Type BEHAVIORAL

Regular Eating pattern

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Intermittent Fasting

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20121102

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCC-21150

Identifier Type: -

Identifier Source: org_study_id