[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643057":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":36,"locations":12,"responsibleParty":46,"collaborators":12,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":12,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":12,"enrollmentInfo":58,"targetDuration":12,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":77,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":12},{"fullName":5,"class":6},"West Virginia University","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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\u002Fday). The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks).",[18],"Behavioral: Alternate-Day Fasting (ADF)",{"label":20,"type":15,"description":21,"interventionNames":22},"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).",[23],"Behavioral: Time-Restricted Eating (TRE)",[25,29],{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":12},"BEHAVIORAL","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.",[14],{"type":26,"name":20,"description":30,"armGroupLabels":31,"otherNames":12},"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.",[20],[33],{"name":34,"affiliation":5,"role":35},"Nour Daboul, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":12,"email":41},"Meg Zafiris","CONTACT","304-293-6065","margaret.zafiris@hsc.wvu.edu",{"name":43,"role":39,"phone":44,"phoneExt":12,"email":45},"Joni Aldinger","304-293-5949","jlaldinger@hsc.wvu.edu",{"type":35,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Nour Daboul","Assistant Professor","100643057","pilot-study-of-intermittent-fasting-with-immune-checkpoint-inhibitors-100643057",false,"NCT07645742","Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors","Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors","Inclusion Criteria:\n\n* Diagnosis of advanced esophageal, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer\n\n  * Planned treatment with ICI-based therapy\n  * ECOG 0-2\n  * Ability to provide informed consent\n  * Willingness to follow dietary guidance and record adherence\n  * BMI = 23-40\n\nExclusion Criteria:\n\n* Diabetes requiring insulin\n\n  * Active eating disorders\n  * Sarcopenia and\u002For cachexia (mild, moderate, severe), including sarcopenic obesity\n  * A history of hypoglycemia, including idiopathic and postbariatric hypoglycemia\n  * Patients taking sulfonylureas (concern for hypoglycemia with fasting)\n  * Night shift workers (at discretion of investigator)\n  * \\>10% weight loss within the past 3 months through self-reporting or chart review.\n  * Any uncontrolled autoimmune condition or recent high-dose steroid use\n  * Severe GI or endocrine disorders precluding fasting including but not limited to malabsorption syndromes, gastroparesis, or Addison's\u002FCushing's\n  * Pregnant or breastfeeding","ALL","18 Years",{"count":59,"type":60},90,"ESTIMATED","INTERVENTIONAL",[63],"NA","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).\n\nParticipants 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.\n\nThe 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.",[66],"Cancer (Advanced Stage)",[68,69,70,71,72,73,74,75,76],"esophogeal","gastric","lung","cholangiocarcinoma","melanoma","Hepatocellular Carcinoma","Immune Checkpoint Inhibitor","Microsatellite Instability-High","Renal Cell Carcinoma","NOT_YET_RECRUITING","2026-06-08",{"date":80,"type":81},"2026-06-12","ACTUAL",{"date":83,"type":60},"2026-07",{"date":85,"type":60},"2029-02",{"name":5,"class":6}]