Time Restricted Eating for Head and Neck Squamous Cell Carcinoma

N/A

Recruiting

Led By Jameel Muzaffar, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent and initiating standard of care immune checkpoint blocker for the first time

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Must not have

Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia

Has received prior therapy with any anti-PD-1, anti-PDL-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if Time Restricted Eating (TRE) can help improve responses in people with metastatic head and neck cancer who are receiving Immune Checkpoint Blockers. They want to see

Who is the study for?

This trial is for adults over 18 with metastatic head and neck squamous cell cancer who are about to start standard immune checkpoint blocker therapy. They should be relatively healthy (ECOG status of 0 or 1) and have a measurable tumor size according to RECIST criteria.

What is being tested?

The study tests if Time Restricted Eating (TRE), which limits eating and drinking to a 10-hour window daily, can improve treatment responses in mHNSCC patients by altering gut bacteria. It also compares outcomes between African American participants and others.

What are the potential side effects?

While the trial primarily investigates TRE, side effects may arise from the underlying immune checkpoint blocker treatments such as fatigue, skin reactions, digestive issues, hormonal changes, inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My head and neck cancer has returned or spread and cannot be cured with surgery or radiation, and I am starting immunotherapy.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes, am pregnant, or have an eating disorder like anorexia or bulimia.

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I have previously been treated with drugs targeting PD-1 or PDL-1.

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I do not have any active infections needing IV antibiotics, severe autoimmune diseases, serious heart issues, uncontrolled diabetes requiring insulin, uncontrolled heart rhythm problems, or mental health/social situations that would affect my study participation.

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I have brain metastases that are either known, untreated, or causing symptoms.