Evaluating Time Restricted Eating for Cancer Treatment
Phase 2, Single Arm Study to Evaluate the Efficacy of Time Restricted Eating (TRE) on Immunotherapy Treatment Outcomes in Patients With Metastatic Head and Neck Squamous Cell Cancer (mHNSCC)
This study is testing if following a specific eating schedule can help improve treatment outcomes for patients with advanced head and neck cancer who are starting immune therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | Nivolumab, pembrolizumab, Atezolizumab, Avelumab, Durvalumab, chemotherapy, radiation, Prednisone |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06603155 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Time Restricted Eating (TRE) on patients with metastatic head and neck squamous cell cancer (mHNSCC) who are starting treatment with immune checkpoint blockers. Participants will follow a specific eating schedule to see if it can enhance their treatment response by altering their gut microbiome. The study will also focus on comparing outcomes between African American participants and the broader participant group. Participants will complete dietary surveys and provide stool and blood samples to assess the impact of TRE on their health and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic head and neck squamous cell cancer who are starting immune checkpoint blocker therapy.
Not a fit: Patients with a BMI under 18.5, diabetes, pregnancy, eating disorders, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment responses for patients with metastatic head and neck cancer.
How similar studies have performed: While the specific combination of TRE and immune checkpoint blockers is novel, similar dietary interventions have shown promise in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jameel Muzaffar, MD — Duke University
- Study coordinator: Marco Reyes
- Email: marco.reyes-martinez@duke.edu
- Phone: 919-613-6973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.