Effect of High Protein Nutritional Supplementation on Nutritional Status, Functional Capacity and Quality of Life in Older Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in Mini Nutritional Assessment (MNA) score
研究概览
简要总结
This interventional prospective randomized controlled study was conducted to compare the effects of high-protein oral nutritional supplement (ONS) and medical nutritional therapy to medical nutrition therapy alone on nutritional status, quality of life, and physical function capacity after neoadjuvant chemotherapy in patients aged 65 and over with newly diagnosed locally advanced gastric cancer.
详细描述
This study is a prospective, randomized controlled trial conducted from February 2023 to February 2024, focusing on the effects of high-protein oral nutritional supplementation (ONS) in older patients (aged 65 and over) with newly diagnosed locally advanced gastric cancer undergoing neoadjuvant chemotherapy (NAC).
Study Design:
The trial involved two groups:
Intervention group (ONS group) - Received ONS in addition to standard medical nutrition therapy.
Control group (non-ONS group) - Received only standard medical nutrition therapy without ONS supplementation.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Aged 65 years or older.
- •Newly diagnosed histological confirmed locally advanced gastric cancer (Stage IIa to IIIa).
- •Scheduled to receive Neoadjuvant chemotherapy.
- •ECOG performance status of 0-
- •Signed informed consent to participate
排除标准
- •Severe comorbidities affecting survival within 3 months.
- •Inability to comply with study procedures.
- •Previous gastric surgery or chemotherapy.
- •Metastatic dissease (Stage IV)
- •Poor performance status (ECOG 3-4)
- •Early satge (Stage I)
结局指标
主要结局
Change in Mini Nutritional Assessment (MNA) score
时间窗: Baseline and 8 Weeks
Unit of Measure: MNA score (Units on a Scale). This will measure changes in nutritional status using the MNA scoring system, which ranges from 0 to 30. A higher score indicates better nutritional status (24-30: normal nutritional status, 17-23.5: at risk of malnutrition, \<17: malnourished).
Change in Handgrip Strength
时间窗: Baseline and 8 Weeks
Unit of Measure: Kilograms (kg). Measured with a hand dynamometer, the average handgrip strength (kg) will be calculated based on three measurements of the dominant hand.
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) score
时间窗: Baseline and 8 Weeks
Unit of Measure: QLQ-C30 score (Units on a Scale). The EORTC QLQ-C30 evaluates quality of life across multiple domains, including physical, emotional, and social functioning. Scores range from 0 to 100, with higher scores indicating better quality of life in functioning scales but worse symptoms when higher scores are in symptom scales.
Change in 'Activities of Daily Living' (ADL) Score
时间窗: Baseline and 8 Weeks
Unit of Measure: ADL score (Units on a Scale). The ADL scale assesses the patient's ability to perform basic daily tasks, such as bathing, dressing, and feeding. Scores range from 0 to 6, with higher scores indicating better physical function and independence.
Change in 'Instrumental Activities of Daily Living' (IADL) Score
时间窗: Baseline and 8 Weeks
Unit of Measure: IADL score (Units on a Scale). The IADL scale evaluates the patient's ability to perform more complex daily tasks, such as managing finances and using transportation. Scores range from 0 to 8, with higher scores reflecting better functional independence.
次要结局
- Change in Body Weight(Baseline and 8 Weeks)
- Change in Body Mass Index (BMI)(Baseline and 8 Weeks)
- Change in Mid-Upper Arm Circumference(Baseline and 8 Weeks)
- Change in Calf Circumference(Baseline and 8 Weeks)
- Changes in Bioelectrical Impedance Analysis (BIA)(Baseline and 8 Weeks)
研究者
Baran Akagündüz
MD, Associate Proffesor
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital