Clinical trial · Interventional
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
NCT05083416CI-TRIAL-00102781completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prolonged Nightly Fasting | Behavioral | — | UNRESOLVED |
| Regular Eating pattern | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Prolonged Nightly Fasting
- description
- Participants will be educated on Prolonged Nightly Fasting (PNF) and the "mycircadianapp". Participants be allowed to choose any 10-hr period that falls between 6 AM- 6 PM, as feeding period. Participants will be recommended to follow study diet guidelines, eat to satiety and not count calories. Participants will be allowed to have water, beverages (\<4 kcal) during the fasting period.
- interventionNames
- Behavioral: Prolonged Nightly Fasting
- type
- ACTIVE_COMPARATOR
- label
- B: Regular Eating pattern
- description
- Participants will follow a traditional eating pattern with no time restrictions.
- interventionNames
- Behavioral: Regular Eating pattern
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * BMI\< 18.5. * 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. * Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.
References
Publications (0)
Data not yet available
No reference posted for this study.