Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC)

Trial Title: Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC)

NCT ID: NCT06603155

Condition: Metastatic Head-and-neck Squamous-cell Carcinoma

Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Squamous Cell

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Time restricted eating (TRE)
Description: TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.
Arm group label: Time Restricted Eating (TRE)

Summary: The purpose of this study is to evaluate whether Time Restricted Eating (TRE) can improve responses in participants with metastatic head and neck squamous cell cancer (mHNSCC) receiving Immune Checkpoint Blockers (ICB) by changing the gut microbiome (the bacteria and other microorganisms living in individual's bodies). A particular focus of this study is to compare the outcomes of African American participants when compared to the rest of the participant population. TRE is a form of intermittent fasting where food and drink intake is limited to a specific time window during the day. The information learned from this study may help researchers develop new strategies to improve outcomes in patients with mHNSCC in the future. Participants will be asked to complete a dietary survey at baseline and week 9 and provide a baseline stool and blood sample. Two weeks before beginning ICB and after participants completed the baseline assessments, they will begin TRE. TRE will be defined as limiting food and drink intake to a 10 hour window during each day and fasting for 14 hours at night. Participants will be asked to complete a daily food log to document the times they eat and drink. On day 1 of ICB and weeks 3, 6, 9, 26, and 52 after ICB, participants will be asked to collect a blood sample and a toxicity assessment will be performed. On day 1 of ICB and weeks 9, 26, and 52 of ICB, participants will be asked to provide a stool sample. Participants will also undergo tumor imaging throughout the study as part of their standard of care assessments. If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or cytologically confirmed 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 - Age ≥18 years, able to understand and voluntarily consent. Exclusion Criteria: - BMI < 18.5. - Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia. - Ongoing or active infection requiring iv antibiotics, autoimmune disease requiring systemic steroids greater than Prednisone 60 mg equivalent, symptomatic congestive heart failure, unstable angina pectoris, insulin use, uncontrolled 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. Eligible patients must be neurologically asymptomatic and not requiring steroids. - Has received prior therapy with any anti-PD-1, anti-PDL-1 - Patients for whom fasting is medically contraindicated

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Duke Cancer Center

Address:
City: Durham
Zip: 27705
Country: United States

Status: Recruiting

Contact:
Last name: Jameel Muzaffar

Start date: November 2024

Completion date: June 2026

Lead sponsor:
Agency: Duke University
Agency class: Other

Source: Duke University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06603155