[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466626":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":23,"locations":24,"responsibleParty":52,"collaborators":23,"id":55,"slug":23,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":23,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":23,"enrollmentInfo":62,"targetDuration":23,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":27,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Diet Arm","ACTIVE_COMPARATOR","control diet arm (\\~20% protein content)",[13],"Other: Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-Protein Diet Arm","intervention low-protein diet arm (10% protein content)",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Diet","Control diet consisting of 20% protein, intervention diet consisting of 10% protein",[9,15],null,[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"University at Buffalo \u002F Great Lakes Cancer Care","RECRUITING","Buffalo","New York","14203","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-78.87837,42.88645,{"lat":37,"lon":36},[40,45,49],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Ashlee Lang, MPH","CONTACT","716-860-0267","alang@kaleidahealth.org",{"name":46,"role":42,"phone":47,"phoneExt":23,"email":48},"Kyle Pasquariello, MA","716-529-6470","kpasquariello@gppconline.com",{"name":50,"role":51,"phone":23,"phoneExt":23,"email":23},"Roberto Pili, MD","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"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":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70,71,72],"Medical Oncology","Integrative Oncology","Medical Nutrition Therapy",[74,75,76],"Oncology","Nutrition","Immunotherapy","2026-03-30",{"date":79,"type":80},"2026-04-03","ACTUAL",{"date":82,"type":80},"2022-05-04",{"date":84,"type":64},"2028-02",{"name":5,"class":6},1]