Clinical trial NCT06603155: Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Head-and-neck Squamous-cell Carcinoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.


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

Primary outcomes:
measure: Median progression free survival (PFS)
timeFrame: 1 Year
measure: 1-year immune related adverse events (irAE) rate
timeFrame: 1 Year
measure: Time restricted eating (TRE) associated change in gut microbiome
timeFrame: Baseline, Day 1, Week 9, Week 26 and Week 52
measure: Time restricted eating (TRE) associated change in metabolome
timeFrame: Baseline, Day 1, Week 9, Week 26 and Week 52
measure: Time restricted eating (TRE) associated change in IGF1
timeFrame: Baseline, Day 1, Week 9, Week 26 and Week 52
measure: Time restricted eating (TRE) associated change in immune repertoire
timeFrame: Baseline, Day 1, Week 9, Week 26 and Week 52
measure: Response to immune checkpoint blocker (ICB) at first response assessment
timeFrame: Week 9
Secondary outcomes:
measure: Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)
timeFrame: Through Week 52
measure: 1-year immune related adverse events (irAE) rate in African American participants
timeFrame: 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jameel Muzaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: