NCT06603155

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

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.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

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

Interventions

Type	Name	Description
BEHAVIORAL	Time restricted eating (TRE)	TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-09-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States