NCT06380101招募中不适用
Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
研究概览
简要总结
This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the rectum
- •Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
- •Eligible for total mesorectal excision
- •No evidence of distant metastasis
- •No prior pelvic radiation therapy
- •No prior chemotherapy
- •Age ≥18 years
排除标准
- •Patients unable to undergo MRI
- •Other anticancer or experimental therapy
- •Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2
- •Serious or refractive cachexia or anorexia
- •Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing
研究组 & 干预措施
Nonessential Amino Acid Restriction (NEAAR) Medical Food
Experimental
This is a single arm study in which all subjects will receive NEAAR medical food.
干预措施: NEAAR Medical Food (Other)
结局指标
主要结局
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
时间窗: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
次要结局
- Absolute and relative change from baseline of circulating non-essential amino acids(from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention)
- molecular ctDNA response.(approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.)
- Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema(approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention)
- Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food(approximately 4 weeks after SCRT with NEAAR medical food intervention)
研究者
研究点 (1)
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