[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05356182":3,"trial-entities:NCT05356182":128,"trial-summary:NCT05356182":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":46,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":14,"eligibility_criteria":73,"std_ages":98,"locations":101,"central_contacts":124,"overall_officials":125,"references":126,"see_also_links":127},"NCT05356182","STUDY00005755","A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies","RECRUITING","2028-02","2026-03","2026-04-03","2022-05-04","State University of New York at Buffalo","OTHER",false,"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.","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).",[18,19,20],"Medical Oncology","Integrative Oncology","Medical Nutrition Therapy",[22,23,24],"Oncology","Nutrition","Immunotherapy","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},30,"ESTIMATED",[33],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Diet","Control diet consisting of 20% protein, intervention diet consisting of 10% protein",[37,38],"Control Diet Arm","Low-Protein Diet Arm",[40,44],{"measure":41,"description":42,"timeFrame":43},"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":41,"description":45,"timeFrame":43},"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.",[47,50,52,54,57,60,63,66,68],{"measure":48,"description":49,"timeFrame":43},"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":48,"description":51,"timeFrame":43},"Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression",{"measure":48,"description":53,"timeFrame":43},"Includes characterization of antigen response by cytokine and chemokine production",{"measure":55,"description":56,"timeFrame":43},"To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention","Enrollment rate",{"measure":58,"description":59,"timeFrame":43},"To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention","Drop-out rate",{"measure":61,"description":62,"timeFrame":43},"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":64,"description":65,"timeFrame":43},"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":64,"description":67,"timeFrame":43},"Progression-Free Survival (PFS)",{"measure":64,"description":69,"timeFrame":43},"Overall Survival(OS)","ALL","18 Years",null,{"inclusion":74,"exclusion":88,"raw_text":97},[75,76,77,78,79,80,81,82,83,84,85,86,87],"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.","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","Life expectancy of at least 6 months","Adults ≥ 18 years of age","Adequate hematologic, renal, and liver function as evidenced by the following:","White blood cell (WBC) ≥ 2,500 cells\u002FμL","Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL","Platelet Count ≥ 100,000 cells\u002FμL","Hemoglobin (HgB) ≥ 9.0 g\u002FdL","Creatinine ≤ 2.0 mg\u002FdL","Total bilirubin ≤ 2 x upper limit of normal (ULN)","Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN","Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN",[89,90,91,92,93,94,95,96],"• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher","Treatment with any of the following medications or interventions within 28 days of registration:","Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.","High dose calcitriol \\[1,25(OH)2VitD\\] (i.e., \\> 7.0 μg\u002Fweek)","A requirement for systemic immunosuppressive therapy for any reason","Any infection requiring parenteral antibiotic therapy or causing fever (temperature \\> 100.5°F or 38.1°C) within 1 week prior to registration","A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging","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","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",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":103,"status":7,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":121},"University at Buffalo \u002F Great Lakes Cancer Care","Buffalo","New York","14203","United States",[109,114,118],{"name":110,"role":111,"phone":112,"email":113},"Ashlee Lang, MPH","CONTACT","716-860-0267","alang@kaleidahealth.org",{"name":115,"role":111,"phone":116,"email":117},"Kyle Pasquariello, MA","716-529-6470","kpasquariello@gppconline.com",{"name":119,"role":120},"Roberto Pili, MD","PRINCIPAL_INVESTIGATOR",{"lat":122,"lon":123},42.88645,-78.87837,[],[],[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[130],"Solid Neoplasm",[],{"nct_id":4,"found":133,"summary":134,"prompt_version":144},true,{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is a randomized, open-label study involving 30 participants. You would be assigned by chance to either a control diet (about 20% protein) or an intervention low-protein diet (10% protein), both alongside immunotherapy.","completed","Low-Protein Diet with Immunotherapy for Solid Tumors","This study is looking at whether a low-protein diet can improve how well immunotherapy works for people with solid tumor cancers. You might be able to join if you have a solid tumor that can be treated with immunotherapies like PD1, PD-L1, or CTLA inhibitors, and you have metastatic disease (cancer that has spread). Researchers want to see if it's practical for patients to follow a low-protein diet while receiving immunotherapy. The study plans to enroll 30 participants, but its current status is unclear. The main idea is that a low-protein diet might help your body's immune system fight cancer more effectively when combined with immunotherapy.","The feasibility of the diet intervention will be measured at 4 months.",106,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]