The Effects of Immunonutrition Therapy on the Nutritional Status, Immune Function, and Quality of Life of Locally Advanced Cervical Cancer Patients With Malnutrition: an Open-label Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?
详细描述
Malnutrition is one of the most common complications in patients with Locally Advanced Cervical Cancer (LACC) undergoing radical concurrent chemoradiotherapy (CCRT). Tumor patients often experience significant immune imbalance, metabolic abnormalities, and inflammatory responses. Immunonutrition therapy involves the use of specific immunonutrients such as polyunsaturated fatty acids, arginine, nucleotides, etc., to prevent and correct malnutrition in cancer patients, regulate immune function, alleviate harmful or excessive inflammatory responses, and thereby improve patients' clinical outcomes.
This study is an open-label randomized controlled trial, including patients with LACC who all receive radical radiotherapy. Using the Nutritional Risk Screening 2002 (NRS2002) at screening, patients identified as having nutritional risk are further assessed by nutritionists and physicians using the Patient-Generated Subjective Global Assessment (PG-SGA) score and modified Global leadership initiative on malnutrition (GLIM) criteria. Patients with moderate or severe malnutrition are randomly allocated into the enteral immunonutrition therapy group (experimental group) and the standard enteral nutrition support group (control group). The experimental group receives immunonutrients per day, while the control group receives isoenergetic standard oral enteral nutrition. Upon admission, all patients receive nutritional education from specialized nurses and consult with nutritionists, and nutritional support is provided during the concurrent chemoradiotherapy for a total of 5 weeks (W0-W5).GLIM score, quality of life score and peripheral blood inflammation and immune indicators were collected within 48 hours after admission (before treatment), W5, W8, and W20; CTCAE v 5.0 score was used for treatment side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Pathological histological diagnosis confirmed as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- •Confirmed as Locally Advanced Cervical Cancer (LACC) based on gynecological examination and imaging assessment;
- •Undergoing CCRT/RT treatment;
- •Patients are conscious, able to communicate without barriers, and able to answer questions.
- •diagnosed with malnutrition according to the GLIM criteria;
排除标准
- •Patients who received neoadjuvant chemotherapy or immunotherapy before treatment;
- •Patients with concomitant other malignant tumors or a history of malignant tumors;
- •Patients with special pathological types of tumors such as cervical small cell carcinoma or neuroendocrine tumors;
- •Patients staged as Ⅳb according to the International Federation of Gynecology and Obstetrics(FIGO) 2018 staging system;
- •Patients with other severe chronic debilitating diseases, such as severe heart failure (New York Heart Association Class II-IV), severe liver damage (alanine aminotransferase ≥ 3 times the upper limit of normal), severe renal insufficiency (GFR < 30 ml/min*1.73 m²), etc.;
- •Eastern Cooperative Oncology Group(ECOG) performance status ≥ 2;
- •Presence of other contraindications to CCRT/RT.
结局指标
主要结局
Dose-limiting toxicity
时间窗: 5-6 weeks
Patients need to receive cisplatin treatment at 40 mg/m2 weekly for 5-6 weeks. During this period, any serious adverse reactions that lead to treatment interruption, delay, or chemotherapy dose reduction are defined as dose-limiting toxicities(DLT).
DLT-free survival
时间窗: 5-6 weeks
Time from start of treatment to onset of DLT
次要结局
- laboratory tests(5-6 weeks, 3 months post-treatment)
- Objective response rate (ORR)(3 months post-treatment)
- compliance(5-6 weeks)
- QoL (Quality of life)(5-6 weeks, 3 months post-treatment)
- Prevalence of malnutrition(5-6 weeks, 3 months post-treatment)
- Prevalence of sarcopenia(5-6 weeks, 3 months post-treatment)
- 2-year overall survival(2 years)
- 2-year progression-free survival(2 years)
研究者
SHUANG ZHENG JIA, PhD
Attending Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences