Could fasting 14 hours a night help cancer immunotherapy work better?
NCT ID NCT06603155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if limiting food intake to a 10-hour window each day (with 14 hours of nightly fasting) could improve how well immunotherapy works in people with advanced head/neck or kidney cancer. Researchers planned to track changes in gut bacteria and immune markers. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- time restricted eating (TRE)
- What this could lead to
- If successful, this could point toward a simple dietary strategy to boost the effectiveness of immunotherapy in certain cancers.
- What could go wrong
- This trial was withdrawn before enrolling any participants, so no data exists. The approach is still very early and unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
-
Nov 2025
An estimate. Start dates often move.
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
HNSCC Cohort Inclusion Criteria: 1. Histologically or cytologically confirmed 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. 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: 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 in a metastatic setting. 6. Patients for whom fasting is medically contraindicated RCC Cohort Inclusion Criteria: 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: 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic head and neck squamous cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke Cancer Center
Durham, North Carolina, 27705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a PET scan reveal who will respond to kidney cancer therapy?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a new drug combo slow advanced head and neck cancer?
- Can a pill boost the immune system to fight Hard-to-Treat cancers?
- Old drug, new hope: mercaptopurine tested against rare cancer syndrome
- Radiation boosts immunotherapy in kidney cancer trial