Collaborative Tele-Nutritional Care for Patients With Stage IV Cancer Undergoing Chemotherapy: The Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- the incidence of cachexia
研究概览
简要总结
In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.
However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.
Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting stage IV cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice.
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
- Single (Outcomes Assessor)
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
- •The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-
- •The patients should be diagnosed, untreated stage IV cancer patients requiring chemotherapy;
- •The patients should have good cognitive and reading abilities to complete questionnaires;
- •The patients should have ≥3 months expected survival period
排除标准
- •Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;
- •Patients with severe diseases affecting digestion, metabolism, or food intake;
- •Presence of contraindications to chemotherapy;
- •Patients in a cachectic state or refractory cachexia;
- •Patients with PG-SGA score ≥9 points
结局指标
主要结局
the incidence of cachexia
时间窗: every month, up to half year
The definition and classification of cancer cachexia was used by an international consensus \[9, 10\]: (1) weight loss \> 5% over the past 6 months (in the absence of simple starvation), (2) BMI \< 20 and any degree of weight loss \> 2%, or (3) appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss \> 2%. The assessment of skeletal muscle depletion was used by mid-upper arm muscle area by anthropometry (men \< 32 cm2, women \< 18 cm2)
次要结局
- Nutritional risk and malnutrition status(every month, up to half year)
- body weight(every month, up to half year)
- Nutritional risk and malnutrition status(every month, up to half year)
研究者
Xingchen Peng
PhD, Professor
West China Hospital