NCT05083416Completed
Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome
Effect of Prolonged Nightly Fasting (PNF) on Immunotherapy Treatment Outcomes in Patients With Advanced Head and Neck Cancer (HNSCC)-Role of Gut Microbiome
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 4 Oct 2021
- Start date
- 20 Oct 2021
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT05083416
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 20 Oct 2021 to the primary completion date, 31 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes mellitus, hyperthyroidism, pregnancy, any eating disorder including anorexia nervosa or bulimia, metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Other
- BMI\< 18.5.
- Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.
Who the study is looking for
- Newly diagnosed 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.