Prolonged Nightly Fasting for Head and Neck Cancer

Overseen by Christine Chung, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christine Chung, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for adults with newly diagnosed, recurrent or metastatic head and neck cancer that can't be treated with surgery or radiation. They should be starting immunotherapy (like Nivolumab) for the first time, have a measurable tumor, and be in good physical condition. People underweight, with uncontrolled illnesses, diabetes, thyroid issues, pregnancy, eating disorders or certain brain metastases cannot join.

Inclusion Criteria

I am fully active or can carry out light work.

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

Patients must have measurable disease as outlined in RECIST version 1.1

Exclusion Criteria

I do not have any severe illnesses or conditions that are not under control.

I have brain metastases but they are treated and not causing symptoms.

I do not have diabetes, thyroid issues, an eating disorder, or a metabolic disorder.

Treatment Details

Interventions

• Prolonged Nightly Fasting (Behavioral Intervention)
• Regular Eating pattern (Behavioral Intervention)

Trial Overview The study tests if eating only during an 8-10 hour window each day without reducing calories improves the effectiveness of immunotherapy in treating head and neck cancer compared to regular eating patterns.

Participant Groups

Group I: A: Prolonged Nightly Fasting Experimental Treatment 1 Intervention

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 II: B: Regular Eating pattern Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Patrick Hwu

H. Lee Moffitt Cancer Center and Research Institute

Chief Executive Officer since 2020

MD from The Medical College of Pennsylvania

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University