WITHDRAWN

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.

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) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)

Quick Facts

Study Start:2025-11

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06603155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 4. Age ≥18 years, able to understand and voluntarily consent.	1. BMI \< 18.5. 2. Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia. 3. 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. 4. Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Eligible patients must be neurologically asymptomatic and not requiring steroids. 5. Has received prior therapy with any anti-PD-1, anti-PDL-1 in a metastatic setting. 6. Patients for whom fasting is medically contraindicated

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
4. Age ≥18 years, able to understand and voluntarily consent.

1. BMI \< 18.5.
2. Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia.
3. 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.
4. Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Eligible patients must be neurologically asymptomatic and not requiring steroids.
5. Has received prior therapy with any anti-PD-1, anti-PDL-1 in a metastatic setting.
6. Patients for whom fasting is medically contraindicated

Contacts and Locations

Principal Investigator

Daniel George, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke Cancer Center

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Duke University

Daniel George, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-11

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

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