Cancer (Advanced Stage)NCT07645742
Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors
A study testing Alternate-Day Fasting (ADF) and Time-Restricted Eating (TRE) in people with Cancer (Advanced Stage), run by West Virginia University.
Trial summary
This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer (Advanced Stage)
- What is being tested?
- Alternate-Day Fasting (ADF) and Time-Restricted Eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced esophageal, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer
- Planned treatment with ICI-based therapy
- ECOG 0-2
- Ability to provide informed consent
- Willingness to follow dietary guidance and record adherence
- BMI = 23-40
Who cannot join
- Diabetes requiring insulin
- Active eating disorders
- Sarcopenia and/or cachexia (mild, moderate, severe), including sarcopenic obesity
- A history of hypoglycemia, including idiopathic and postbariatric hypoglycemia
- Patients taking sulfonylureas (concern for hypoglycemia with fasting)
- Night shift workers (at discretion of investigator)
Show all 10Show fewer
- >10% weight loss within the past 3 months through self-reporting or chart review.
- Any uncontrolled autoimmune condition or recent high-dose steroid use
- Severe GI or endocrine disorders precluding fasting including but not limited to malabsorption syndromes, gastroparesis, or Addison's/Cushing's
- Pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors
This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Participants will be assigned to 1 of 3 groups: usual care with no fasting, alternate-day fasting (ADF), or time-restricted eating (TRE).
Participants in the ADF group will follow cycles of 12 hours of eating followed by 36 hours of fasting every other day. Participants in the TRE group will eat all daily calories within an 8-hour window each day. The fasting intervention will begin within 1 week of starting ICI treatment and continue for approximately 20-24 weeks during 8 cycles of therapy.
The study will evaluate adherence to the fasting regimens and compare side effects between groups. Researchers will also study changes in metabolic and immune biomarkers, fatigue, sleep, and quality of life. Participants will be followed for 30 days after completion of the intervention to monitor safety and tolerability.
- Conditions
- Cancer (Advanced Stage)
- Being tested
- Alternate-Day Fasting (ADF), Time-Restricted Eating (TRE)
- Keywords
- esophogeal, gastric, lung, cholangiocarcinoma, melanoma, Hepatocellular Carcinoma, Immune Checkpoint Inhibitor, Microsatellite Instability-High, Renal Cell Carcinoma
- Medical subject headings
- Neoplasms, Cholangiocarcinoma, Melanoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate-Day Fasting (ADF)Behavioural
Participants will follow an alternate-day fasting regimen during ICI therapy consisting of approximately 12 hours of eating followed by 36 hours of fasting every other day.
Time-Restricted Eating (TRE)Behavioural
Participants will follow a time-restricted eating regimen during ICI therapy by consuming all daily calories within an 8-hour window each day, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care, No Fasting | No intervention | Participants will receive standard nutrition education materials per institutional practice. No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy. |
| Alternate-Day Fasting (ADF) | Experimental | Participants will follow a repeating cycle of approximately 12 hours of eating followed by 36 hours of fasting every other day during ICI therapy. During fasting periods, participants may consume plain coffee, sugar-free tea, sugar-free herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear vegetable or meat broth (up to 500 kcal/day). The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks). Receives: Behavioral: Alternate-Day Fasting (ADF) |
| Time-Restricted Eating (TRE) | Experimental | Participants will consume all daily calories within an 8-hour eating window each day during ICI therapy, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later. Outside the eating window, participants may consume plain coffee, tea, herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear broth. The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks). Receives: Behavioral: Time-Restricted Eating (TRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Assigned Intermittent Fasting Regimen
Adherence will be assessed using participant-completed fasting diaries. For the time-restricted eating (TRE) arm, adherence is defined as meeting the assigned fasting window on ≥5 days per week.
For the alternate-day fasting (ADF) arm, adherence is defined as meeting fasting-day criteria on ≥5 days within each 14-day period.
Adherence will be summarized as the proportion of participants who meet the assigned regimen-specific adherence criteria during the study period.
Measured: Up to approximately 24 weeks (8 treatment cycles)
Secondary outcomes (1)
Incidence of Adverse Events
Adverse events (AEs) and immune-related AEs (irAE) will be summarized and compared descriptively between study arms. Events will be graded according to CTCAE. The proportion of participants experiencing irAEs, including grade ≥3 irAEs, will be summarized by treatment group.
Measured: Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Advanced Stage)Studies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Daboul, West Virginia University
- Investigators
- Nour Daboul, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645742
- Sponsor's protocol ID
- STUDY00000260
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07645742
- Acronym / sponsor ID
- STUDY00000260
- Conditions
- Cancer (Advanced Stage)
- Keywords
- esophogeal, gastric, lung, cholangiocarcinoma, melanoma, Hepatocellular Carcinoma, Immune Checkpoint Inhibitor, Microsatellite Instability-High
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Participants will be assigned to 1 of 3 groups: usual care with no fasting, alternate-day fasting (ADF), or time-restricted eating (TRE).
Participants in the ADF group will follow cycles of 12 hours of eating followed by 36 hours of fasting every other day. Participants in the TRE group will eat all daily calories within an 8-hour window each day. The fasting intervention will begin within 1 week of starting ICI treatment and continue for approximately 20-24 weeks during 8 cycles of therapy.
The study will evaluate adherence to the fasting regimens and compare side effects between groups. Researchers will also study changes in metabolic and immune biomarkers, fatigue, sleep, and quality of life. Participants will be followed for 30 days after completion of the intervention to monitor safety and tolerability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care, No Fasting | No intervention | –Participants will receive standard nutrition education materials per institutional practice. No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy. |
| Alternate-Day Fasting (ADF) | Experimental | Behavioral: Alternate-Day Fasting (ADF)Participants will follow a repeating cycle of approximately 12 hours of eating followed by 36 hours of fasting every other day during ICI therapy. During fasting periods, participants may consume plain coffee, sugar-free tea, sugar-free herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear vegetable or meat broth (up to 500 kcal/day). The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks). |
| Time-Restricted Eating (TRE) | Experimental | Behavioral: Time-Restricted Eating (TRE)Participants will consume all daily calories within an 8-hour eating window each day during ICI therapy, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later. Outside the eating window, participants may consume plain coffee, tea, herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear broth. The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of advanced esophageal, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer
Key exclusion criteria (10 listed)
- Diabetes requiring insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate-Day Fasting (ADF)Participants will follow an alternate-day fasting regimen during ICI therapy consisting of approximately 12 hours of eating followed by 36 hours of fasting every other day. | Behavioural | Alternate-Day Fasting (ADF) |
| Time-Restricted Eating (TRE)Participants will follow a time-restricted eating regimen during ICI therapy by consuming all daily calories within an 8-hour window each day, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later. | Behavioural | Time-Restricted Eating (TRE) |
Primary outcome
Adherence to Assigned Intermittent Fasting Regimen
Time frame: Up to approximately 24 weeks (8 treatment cycles)
Adherence will be assessed using participant-completed fasting diaries. For the time-restricted eating (TRE) arm, adherence is defined as meeting the assigned fasting window on ≥5 days per week. For the alternate-day fasting (ADF) arm, adherence is defined as meeting fasting-day criteria on ≥5 days within each 14-day period. Adherence will be summarized as the proportion of participants who meet the assigned regimen-specific adherence criteria during the study period.
1 secondary outcome
Incidence of Adverse Events
Time frame: Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nour Daboul, MD principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A study testing Alternate-Day Fasting (ADF) and Time-Restricted Eating (TRE) in people with Cancer (Advanced Stage), run by West Virginia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meg Zafiris (304-293-6065, margaret.zafiris@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Assigned Intermittent Fasting Regimen (time frame: Up to approximately 24 weeks (8 treatment cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.