Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603155
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Time Restricted Eating TRE in Metastatic Head and Neck Squamous Cell Cancer mHNSCC
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals 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of care assessments If a participants disease progresses after ICB they will repeat all study assessments and be withdrawn from the study
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 participants disease progresses after ICB they will repeat all study assessments and be withdrawn from the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None