Time Restricted Eating for Head and Neck Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen by Jameel Muzaffar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Must be taking: Immune checkpoint blockers

Must not be taking: Systemic steroids, Insulin

Disqualifiers: Diabetes, Pregnancy, Eating disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on systemic steroids greater than Prednisone 60 mg or insulin, you may not be eligible to participate.

What data supports the effectiveness of the treatment Time Restricted Eating (TRE) for head and neck squamous cell carcinoma?

While there is no direct evidence for Time Restricted Eating (TRE) in head and neck cancer, studies show that maintaining a good diet quality and nutritional support can improve survival and prognosis in these patients. Nutritional interventions are important as weight loss is common and can worsen outcomes. ^{1 2 3 4 5}

Is Time Restricted Eating safe for humans?

The provided research articles do not contain specific safety data on Time Restricted Eating or similar dietary patterns like Intermittent Fasting for humans. Therefore, no relevant safety information is available from these studies. ^{1 5 6 7 8}

How is Time Restricted Eating different from other treatments for head and neck squamous cell carcinoma?

Time Restricted Eating (TRE) is unique because it focuses on limiting the time window for eating rather than changing the types of food consumed, which is different from traditional dietary interventions that often emphasize specific nutrients or food groups. This approach may help manage weight and improve overall health, which is particularly important for head and neck cancer patients who often face nutritional challenges. ^{4 5 7 8 9}

Research Team

Jameel Muzaffar, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

I am 18 or older and can understand and agree to participate on my own.

Exclusion Criteria

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

Patients for whom fasting is medically contraindicated

BMI < 18.5

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants begin Time Restricted Eating (TRE) two weeks before starting Immune Checkpoint Blockers (ICB) and complete baseline assessments

2 weeks

1 visit (in-person)

Treatment

Participants receive Immune Checkpoint Blockers (ICB) and continue Time Restricted Eating (TRE) with regular blood and stool sample collections and toxicity assessments

52 weeks

Visits at Day 1, Weeks 3, 6, 9, 26, and 52

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and immune-related adverse events

1 year

Treatment Details

Interventions

• Time Restricted Eating (TRE) (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Time Restricted Eating (TRE) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

In a study of 20 head and neck cancer patients, most experienced a negative energy balance both at the start of and after radiotherapy, indicating that their energy expenditure exceeded their energy intake.

The lack of significant changes in energy intake and expenditure during treatment highlights the critical need for nutritional support to prevent involuntary weight loss in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An explorative study on energy balance in patients with head and neck cancer. Einarsson, S., Laurell, G., Tiblom Ehrsson, Y.[2021]

In a study of 110 patients with head and neck cancer undergoing treatment, the need for enteral nutrition (EN) significantly increased due to treatment-related toxicities, particularly from week 3 to 4, highlighting the importance of monitoring these toxicities.

Patients experiencing more severe dysphagia (grade 2-3) were less likely to stop EN, suggesting that assessing acute toxicities can help guide timely EN initiation and predict its duration, potentially preventing nutritional decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral nutrition support and treatment toxicities in patients with head and neck cancer receiving definitive or adjuvant helical intensity-modulated radiotherapy with concurrent chemotherapy. Blake, CL., Brown, TE., Pelecanos, A., et al.[2023]

Head and neck cancer patients are at high risk for malnutrition and refeeding syndrome (RFS), which can lead to serious fluid and electrolyte imbalances if not managed properly.

Early nutritional assessment and intervention are essential for preventing RFS in these patients, highlighting the need for a multidisciplinary approach to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition and refeeding syndrome prevention in head and neck cancer patients: from theory to clinical application. Kaderbay, A., Atallah, I., Fontaine, E., et al.[2021]

Refeeding syndrome is a serious and potentially fatal condition that can occur in head and neck cancer patients after a period of starvation, characterized by dangerous electrolyte shifts and metabolic complications.

To prevent refeeding syndrome, it is crucial to start refeeding at a low rate of 10 kcal/kg per day for at-risk patients, particularly those with dysphagia, and to provide vitamin supplements during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refeeding syndrome--awareness, prevention and management. Mehanna, H., Nankivell, PC., Moledina, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

An explorative study on energy balance in patients with head and neck cancer. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Head and neck cancer patients included at home enteral nutrition by tube]. [2013]

3. Australia pubmed.ncbi.nlm.nih.gov

Weight loss in head and neck cancer patients little noticed in general practice. [2010]

4. Germany pubmed.ncbi.nlm.nih.gov

Nutritional support for head and neck cancer patients receiving radiotherapy: a systematic review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to a priori-Defined Diet Quality Indices Throughout the Early Disease Course Is Associated With Survival in Head and Neck Cancer Survivors: An Application Involving Marginal Structural Models. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Enteral nutrition support and treatment toxicities in patients with head and neck cancer receiving definitive or adjuvant helical intensity-modulated radiotherapy with concurrent chemotherapy. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Malnutrition and refeeding syndrome prevention in head and neck cancer patients: from theory to clinical application. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Refeeding syndrome--awareness, prevention and management. [2021]

9. Scotland pubmed.ncbi.nlm.nih.gov

Food restrictions of patients who are undergoing treatment for oral and oropharyngeal cancer. [2015]