A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical study is to learn whether oral histidine supplementation may be safely used to support antitumor immune function during standard colorectal cancer treatment.
Participants with colorectal cancer in the supplementation group will:
Take 2g oral histidine once daily during standard colorectal cancer treatment; Provide blood samples before and after supplementation; Attend regular follow-up visits for laboratory tests, safety assessment, and treatment evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years, regardless of sex.
- •Body mass index (BMI) ≥18.
- •NRS-2002 score <
- •Diagnosed with stage II or higher colorectal cancer who require pharmacological intervention.
- •Capable of oral intake of medication.
- •Willing to participate in the study and provide written informed consent.
排除标准
- •Participation in other interventional clinical trials (including drugs, nutritional supplements, medical devices, etc.) within 4 weeks prior to enrollment.
- •Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding.
- •Allergy to sample components.
- •Current use of other nutritional supplements that may affect the validity and effectiveness of the study results.
- •Pregnant, lactating female patients or women with fertility who test positive in the baseline pregnancy test.
- •Presence of cognitive impairments or mental illnesses that prevent understanding of the study procedures.
- •Presence of any other conditions, judged by the researcher, make the participant unsuitable for participation in the study.
研究组 & 干预措施
Histidine supplement group
Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks.
干预措施: Histidine (Dietary Supplement)
研究者
Jing-yuan Fang, MD, Ph. D
Professor Dr. Jing-yuan Fang
Shanghai Jiao Tong University School of Medicine