[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466626":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":58,"overallOfficials":39,"centralContacts":39,"locations":63,"responsibleParty":91,"collaborators":39,"id":94,"slug":39,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":39,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":39,"enrollmentInfo":101,"targetDuration":39,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":66,"whyStopped":39,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.","Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.","4 Months",{"measure":10,"description":14,"timeFrame":12},"Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.",[16,19,21,23,26,29,32,35,37],{"measure":17,"description":18,"timeFrame":12},"To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies","Includes isolation and characterization of antigen specific T cell clones",{"measure":17,"description":20,"timeFrame":12},"Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression",{"measure":17,"description":22,"timeFrame":12},"Includes characterization of antigen response by cytokine and chemokine production",{"measure":24,"description":25,"timeFrame":12},"To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention","Enrollment rate",{"measure":27,"description":28,"timeFrame":12},"To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention","Drop-out rate",{"measure":30,"description":31,"timeFrame":12},"To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention","Compliance with diet measured by self-report of patient",{"measure":33,"description":34,"timeFrame":12},"To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria","Objective Response Rate (ORR)",{"measure":33,"description":36,"timeFrame":12},"Progression-Free Survival (PFS)",{"measure":33,"description":38,"timeFrame":12},"Overall Survival(OS)",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Control Diet Arm","ACTIVE_COMPARATOR","control diet arm (\\~20% protein content)",[53],"Other: Diet",{"label":55,"type":50,"description":56,"interventionNames":57},"Low-Protein Diet Arm","intervention low-protein diet arm (10% protein content)",[53],[59],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":39},"Diet","Control diet consisting of 20% protein, intervention diet consisting of 10% protein",[49,55],[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"University at Buffalo \u002F Great Lakes Cancer Care","RECRUITING","Buffalo","New York","14203","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-78.87837,42.88645,{"lat":76,"lon":75},[79,84,88],{"name":80,"role":81,"phone":82,"phoneExt":39,"email":83},"Ashlee Lang, MPH","CONTACT","716-860-0267","alang@kaleidahealth.org",{"name":85,"role":81,"phone":86,"phoneExt":39,"email":87},"Kyle Pasquariello, MA","716-529-6470","kpasquariello@gppconline.com",{"name":89,"role":90,"phone":39,"phoneExt":39,"email":39},"Roberto Pili, MD","PRINCIPAL_INVESTIGATOR",{"type":90,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Roberto Pili","Associate Dean for Cancer Research and Integrative Oncology","100466626",false,"NCT05356182","A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies","Inclusion Criteria:\n\n* Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.\n* Metastatic disease as evidenced by soft tissue and\u002For bony metastases on baseline bone scan and\u002For computed tomography (CT) scan of the chest, abdomen, and pelvis\n* Life expectancy of at least 6 months\n* Adults ≥ 18 years of age\n* Adequate hematologic, renal, and liver function as evidenced by the following:\n\n  * White blood cell (WBC) ≥ 2,500 cells\u002FμL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL\n  * Platelet Count ≥ 100,000 cells\u002FμL\n  * Hemoglobin (HgB) ≥ 9.0 g\u002FdL\n  * Creatinine ≤ 2.0 mg\u002FdL\n  * Total bilirubin ≤ 2 x upper limit of normal (ULN)\n  * Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN\n  * Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN\n\nExclusion Criteria:\n\n* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher\n\n  * Treatment with any of the following medications or interventions within 28 days of registration:\n\n    * Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.\n    * High dose calcitriol \\[1,25(OH)2VitD\\] (i.e., \\> 7.0 μg\u002Fweek)\n  * A requirement for systemic immunosuppressive therapy for any reason\n  * Any infection requiring parenteral antibiotic therapy or causing fever (temperature \\> 100.5°F or 38.1°C) within 1 week prior to registration\n  * A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging\n  * Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives","ALL","18 Years",{"count":102,"type":103},30,"ESTIMATED","INTERVENTIONAL",[106],"NA","The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.",[109,110,111],"Medical Oncology","Integrative Oncology","Medical Nutrition Therapy",[113,114,115],"Oncology","Nutrition","Immunotherapy","2026-03-30",{"date":118,"type":119},"2026-04-03","ACTUAL",{"date":121,"type":119},"2022-05-04",{"date":123,"type":103},"2028-02",{"name":5,"class":6},1]