Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy
Conditions
Keywords
Sarcopenia; Cancer; Chemotherapy; Nutritional Supplement; ETHANWELL BALANCED; Muscle Strength; BCAA; Beta-glucan; Protein Intake; Fatigue
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTETHANWELL 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.
BEHAVIORALElastic 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.
Sponsors
Ethan Nutraceutical Co., Ltd.
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 40 and above. 2. Patients receiving chemotherapy or expected to undergo thoracic surgery (stage I\ IV) 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and SARC-F score ≥ 4. 4. Grip strength: \<28kg for males and \<18kg for females. 5. Conscious and able to communicate.
Exclusion criteria
1. Central nervous system disorders and chronic kidney failure. 2. Mental illness or inability to cooperate. 3. Expected survival period less than 3 months. 4. Gastrointestinal dysfunction-patients who have undergone gastric resection surgery or have intestinal obstruction. 5. Heart failure-NYHA class IV. 6. Uncontrollable infection diagnosed by a physician. 7. Poorly controlled diabetes diagnosed by a physician. 8. End-stage renal disease-requiring hemodialysis or peritoneal dialysis. 9. Liver cirrhosis with severe ascites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve hand grip strength (HGT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assesses changes in cancer-related fatigue using a validated Taiwanese version of the Brief Fatigue Inventory. |
| Change in Quality of Life (EORTC QLQ-C30) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12 | Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Assesses patient-reported physical, emotional, and social well-being. |
| Change in Inflammatory Markers: IL-6, CRP, TNF-α | Baseline, Week 4, Week 12 | Blood samples are analyzed for interleukin-6, C-reactive protein, and tumor necrosis factor-alpha to evaluate systemic inflammation related to sarcopenia and nutritional status. |
| Change in Mid-Upper Arm Circumference (MUAC) | Baseline, Week 2, Week 4, Week 8, Week 12 | Assesses changes in muscle mass via measurement of mid-upper arm circumference using the same standardized tape throughout the study. |
Countries
Taiwan
Outcome results
None listed