Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
NCT ID: NCT06603155
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-11-30
2026-06-30
Brief Summary
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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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Time Restricted Eating (TRE) for mHNSCC participants
Time restricted eating (TRE)
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)
TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.
Interventions
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Time restricted eating (TRE)
TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.
Eligibility Criteria
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Inclusion Criteria
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. 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.
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.
Exclusion Criteria
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
RCC Cohort
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
6. Patients for whom fasting is medically contraindicated
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel George, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Cancer Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00115641
Identifier Type: -
Identifier Source: org_study_id