Improving Sarcopenia During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Improve hand grip strength (HGT)
研究概览
简要总结
This study aims to investigate whether a high-protein nutritional supplement (ETHANWELL BALANCED) can help improve muscle strength and reduce fatigue in cancer patients who are at risk of sarcopenia (age- or disease-related muscle loss) during chemotherapy. Sarcopenia is common in older adults and cancer patients and can lead to weakness, poor treatment tolerance, and reduced quality of life.
Participants aged 40 and older, receiving chemotherapy, and showing early signs of sarcopenia will be randomly assigned to two groups. The experimental group will receive nutritional education and take a high-protein nutritional drink three times per day for 8 weeks. Both groups will continue their usual medical care and perform simple resistance exercises at home.
Researchers will measure changes in grip strength, fatigue, quality of life, and nutritional status over a 12-week period. This study will help determine whether early nutrition intervention can improve treatment outcomes and quality of life for cancer patients with sarcopenia.
详细描述
Sarcopenia is a condition characterized by loss of muscle mass and strength, frequently observed in older adults and patients undergoing cancer treatment. It contributes to poor treatment tolerance, increased fatigue, longer hospital stays, and reduced quality of life. Early nutritional support may help reduce these complications.
This study is a prospective, randomized controlled trial investigating the effects of a high-protein oral nutritional supplement (ETHANWELL BALANCED) on muscle strength, fatigue, and quality of life in cancer patients with early-stage sarcopenia during chemotherapy. Participants will be randomly assigned to either an intervention group or a control group in a 2:1 ratio.
The intervention group will receive nutritional counseling and consume three servings of ETHANWELL BALANCED per day for 8 weeks, in addition to performing home-based resistance exercises. The control group will receive standard care and perform the same exercises. Follow-up assessments will occur at baseline and at weeks 1, 2, 4, 8, and 12.
The primary aim is to determine whether early nutritional intervention can slow the progression of sarcopenia and improve patient outcomes during cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 and above.
- •Patients receiving chemotherapy or expected to undergo thoracic surgery (stage I~IV)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and SARC-F score ≥
- •Grip strength: <28kg for males and <18kg for females.
- •Conscious and able to communicate.
排除标准
- •Central nervous system disorders and chronic kidney failure.
- •Mental illness or inability to cooperate.
- •Expected survival period less than 3 months.
- •Gastrointestinal dysfunction-patients who have undergone gastric resection surgery or have intestinal obstruction.
- •Heart failure-NYHA class IV.
- •Uncontrollable infection diagnosed by a physician.
- •Poorly controlled diabetes diagnosed by a physician.
- •End-stage renal disease-requiring hemodialysis or peritoneal dialysis.
- •Liver cirrhosis with severe ascites.
结局指标
主要结局
Improve hand grip strength (HGT)
时间窗: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12
Measured using an electronic hand dynamometer. Assesses change in muscle strength over the course of 12-week intervention.
次要结局
- Change in Inflammatory Markers: IL-6, CRP, TNF-α(Baseline, Week 4, Week 12)
- Change in Mid-Upper Arm Circumference (MUAC)(Baseline, Week 2, Week 4, Week 8, Week 12)
- Improve body weight(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12)
- Change in Brief Fatigue Inventory - Taiwanese version (BFI-T) Score(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12)
- Change in Quality of Life (EORTC QLQ-C30)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12)