Improving Sarcopenia in Cancer Patients Undergoing Chemotherapy With High-Protein Nutritional Supplementation

Официальное название

Improving Sarcopenia During Chemotherapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка ETHANWELL BALANCED
  A nutritional powder providing 250 kcal, 13.5 g protein (including 6.75 g whey protein and 2740 mg BCAAs), and 166.953 mg POLYCAN® (β-glucan) per serving. Administered 3 times daily for 8 weeks.
• Поведенческое Elastic Band Training
  Participants perform 5 specific resistance exercises (push up \& press down, straight arm lift, seated rowing, squat, seated leg raise). Each exercise is done in 3 sets of 10 reps, 3 times per week, for 8 weeks.

Первичные конечные точки

• Improve hand grip strength (HGT) [Срок оценки: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]

Вторичные конечные точки (5)

• Improve body weight [Срок оценки: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
• Change in Brief Fatigue Inventory - Taiwanese version (BFI-T) Score [Срок оценки: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
• Change in Quality of Life (EORTC QLQ-C30) [Срок оценки: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
• Change in Inflammatory Markers: IL-6, CRP, TNF-α [Срок оценки: Baseline, Week 4, Week 12]
• Change in Mid-Upper Arm Circumference (MUAC) [Срок оценки: Baseline, Week 2, Week 4, Week 8, Week 12]

Критерии участия

Критерии включения

• 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 ≥ 4.
• Grip strength: <28kg for males and <18kg for females.
• Conscious and able to communicate.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital (NTUH) — Taipei

Публикации

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• Preventing effects of exopolymers purified from (EAP) supplementation and resistance exercise on muscle aging and loss in the Korean elderly: a randomized controlled trial (vol 13, pg 237, 2021). Toxicology and Environmental Health Sciences, 2021. 13(4): p. 429-429.
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Идентификаторы

NCT: NCT07114588 · 202409133RIFE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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