Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)

NCT06603155 | Withdrawn

• 1 other identifier: Pro00115641
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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) or unresectable/metastatic renal cell carcinoma (RCC) 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 and RCC 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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.

Conditions

Unresectable Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Head-and-neck Squamous-cell Carcinoma

Outcome Measures

Primary Outcomes (6)

• Median progression free survival (PFS) for HNSCC cohort only

  Time from enrollment to radiographic disease progression as per RECIST 1.1 or death from any cause

  1 Year

• Time restricted eating (TRE) associated change in gut microbiome

  Microbiome changes in stool

  Baseline, Day 1, Week 9, Week 26 and Week 52

• Time restricted eating (TRE) associated change in metabolome

  Metabolomics in blood

  Baseline, Day 1, Week 9, Week 26 and Week 52

• Time restricted eating (TRE) associated change in IGF1

  IGF1 level in blood

  Baseline, Day 1, Week 9, Week 26 and Week 52

• Time restricted eating (TRE) associated change in immune repertoire

  Comprehensive analysis of effector T cells and suppressor T cell populations in PBMC, plasma cytokines will be carried out

  Baseline, Day 1, Week 9, Week 26 and Week 52

• Response to immune checkpoint blocker (ICB) at first response assessment

  Radiographic response as per RECIST 1.1

  Week 9

Secondary Outcomes (4)

• 1-year immune related adverse events (irAE) rate

  1 Year

• Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)

  Through Week 52

• 1-year immune related adverse events (irAE) rate in African American participants

  1 year

• Median progression free survival (PFS) for RCC cohort only

  1 Year

Study Arms (2)

Time Restricted Eating (TRE) for mHNSCC participants

EXPERIMENTAL

Behavioral: Time restricted eating (TRE)

Time Restricted Eating (TRE) for RCC participants

EXPERIMENTAL

Behavioral: Time restricted eating (TRE)

Interventions

Time restricted eating (TRE) BEHAVIORAL

TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.

Time Restricted Eating (TRE) for RCC participants; Time Restricted Eating (TRE) for mHNSCC participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 in a metastatic setting.
• Patients for whom fasting is medically contraindicated
• RCC Cohort
• Histologically or cytologically confirmed unresectable/metastatic clear cell renal cell carcinoma that is not amenable to local therapy with curative intent (surgery, radiation therapy, cryoablation, etc.,) and initiating standard of care systemic therapy consisting of immune checkpoint blockade (e.g. ipilimumab/nivolumab, cabozantinib/nivolumab, lenvatinib/pembrolizumab, or axitinib/pembrolizumab) 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.
• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Daniel George, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)