A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/or bony metastases on baseline bone scan and/or 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/μL
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
- •Platelet Count ≥ 100,000 cells/μL
- •Hemoglobin (HgB) ≥ 9.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •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
排除标准
- •• 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/week)
- •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
研究组 & 干预措施
Control Diet Arm
control diet arm (~20% protein content)
干预措施: Diet (Other)
Low-Protein Diet Arm
intervention low-protein diet arm (10% protein content)
干预措施: Diet (Other)
结局指标
主要结局
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
时间窗: 4 Months
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.
次要结局
- 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(4 Months)
- To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention(4 Months)
- To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention(4 Months)
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies(4 Months)
- To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention(4 Months)
研究者
Roberto Pili
Associate Dean for Cancer Research and Integrative Oncology
State University of New York at Buffalo