[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fasting-intermittent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fasting-intermittent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100652836","phase-2-16-hour-fasting-plus-serplulimab-and-capeox-as-neoadjuvant-therapy-in-pmmrmss-advanced-mid-to-low-rectal-cancer-100652836",false,"NCT07779694","16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR\u002FMSS Advanced Mid-to-Low Rectal Cancer","Neoadjuvant 16-Hour Fasting Combined With Serplulimab and CAPEOX for pMMR\u002FMSS Locally Advanced Mid-to-Low Rectal Cancer: A Prospective, Single-Arm, Phase II Trial.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Male or female subjects ≧ 18 years ≦ 75 of age.\n3. Histological or cytological documentation of adenocarcinoma of the rectum.\n4. No previous any systemic anticancer therapy for rectal cancer disease.\n5. The primary rectal tumor is assessed as likely to be R0 resectable by a multidisciplinary colorectal cancer collaborative team, comprising at least 2 gastrointestinal surgeons and 1 radiologist.\n6. The lower margin of the tumor is less than 10cm from the anus verge.\n7. cT2N1-2M0, cT3N0-2M0, cT4N0-1M0 MSS with MRF(-) assessed by MRI.\n8. Primary tumor can be detected by CT or MRI.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n10. Eligible tumor tissues were identified for MSI\u002FMMR assays.\n11. Hepatitis B Surface Antigen (HBsAg) (-).\n12. If HBsAg (+) , HBV-DNA must be less than 2500 copies\u002FmL or 500 IU\u002FmL to be enrolled.\n13. Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies).\n\nExclusion Criteria:\n\n1. Patients with recurrent rectal cancer or a history of pelvic radiotherapy.\n2. Patients with a history of inflammatory bowel disease.\n3. Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded.\n4. Patients who are preparing for or have previously received an organ or bone marrow transplant.\n5. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula).\n6. According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) \\\u003C50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n7. Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n8. Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted.\n9. The patients had previously been treated with other antibodies\u002Fdrugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4).\n10. Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study.\n11. Uncontrolled tumor-related pain.\n12. A known history of severe allergy to any monoclonal antibody.\n13. Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients.\n14. Pregnant or lactating women.\n15. The investigators determined that the patient had other factors that might have led to the early termination of the study.","ALL","18 Years","75 Years",{"count":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Although standard neoadjuvant chemoradiotherapy (nCRT) for locally advanced rectal cancer (LARC) effectively reduces local recurrence, radiotherapy-related toxicities and surgical complications severely impair patients' quality of life, making a radiotherapy-free strategy urgently needed. However, chemotherapy alone yields a pathological complete response (pCR) rate of only 6.6%-15%, which is far from satisfactory.\n\nThe pMMR\u002FMSS subtype, accounting for 90% of rectal cancers, is \"immune-cold\" and shows almost no response to PD-1 monotherapy; nonetheless, chemotherapy can reshape the tumor immune microenvironment, and multiple studies have demonstrated that combining chemotherapy with PD-1 inhibitors (without radiotherapy) can elevate pCR rates to 26.8%-42.9%, yet further improvement remains desirable. A recent mechanistic study published in Cell Metabolism (2026) revealed that a single 16-hour fasting episode before treatment promotes isoleucine accumulation in the tumor microenvironment, which enhances CD8+T-cell cytotoxic function and reduces exhaustion through acetyl-CoA metabolism and epigenetic reprogramming, thereby significantly sensitizing PD-1 inhibitors-and this intervention is non-invasive, low-cost, and easily adoptable by patients.\n\nBased on the above evidence, we hypothesize that the neoadjuvant triple-combination regimen of \"16-hour fasting + chemotherapy + PD-1 inhibitor\" (radiotherapy-free) in pMMR\u002FMSS locally advanced mid-to-low rectal cancer may further increase pCR rates and tumor regression, offering a novel, highly effective, and low-toxicity therapeutic option for LARC patients.",[27,28,29],"pMMR\u002FMSS","Locally Advanced Rectal Carcinoma","Fasting, Intermittent",[31,32,33,34,35],"Rectal cancer","Serplulimab","CAPEOX","neoadjuvant therapy","16-hour fasting","NOT_YET_RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":21},"2026-09-01",{"date":44,"type":21},"2029-12-31",{"name":46,"class":47},"Zhejiang University","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100553163","phase-2-take-the-reins-the-effects-of-nutrient-timing-on-cancer-related-fatigue-100553163","NCT06482515","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)","Inclusion criteria (Participants must…):\n\n* Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);\n* Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for \\>2 months and expected to stay on it until progression is okay);\n* Have a baseline level of fatigue, as determined by at least one of the following:\n\n  1. Reporting a score of 4 or higher in response to the question, \"What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?\"\n  2. In the habit of taking daytime naps,\n  3. Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,\n* Be able to speak and\u002For read and write in English or Spanish;\n* Be at least 18 years old; and\n* Be able to provide informed consent.\n\nExclusion criteria (participants must not…)\n\n* Be underweight, as defined as a body mass index \\\u003C18.5 kg\u002Fm2;\n* Already eat all their food within a window that is 10 h or shorter most (6\u002F7) days of the week;\n* Be employed in a job where they regularly work away from the home at night (e.g., night shift);\n* Have surgery planned during the study duration;\n* Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder);\n* Be taking insulin; or\n* Be on enteral or parenteral nutrition.",{"count":56,"type":21},96,[24],"Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.",[60,61,62,63,64,29],"Neoplasms","Blood Cancer","Fatigue","Diet Habit","Survivorship","RECRUITING","2026-06-03",{"date":68,"type":40},"2026-06-05",{"date":70,"type":40},"2024-11-04",{"date":72,"type":21},"2028-08-31",{"name":74,"class":47},"University of Maryland, Baltimore",1]