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| Name | Class |
|---|---|
| Ethan Nutraceutical Co., Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement + Elastic Band Training | Experimental |
| |
| Routine Care (Control Group) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETHANWELL BALANCED | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improve hand grip strength (HGT) | Measured using an electronic hand dynamometer. Assesses change in muscle strength over the course of 12-week intervention. | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Improve body weight | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12 | |
| Change in Brief Fatigue Inventory - Taiwanese version (BFI-T) Score | Assesses changes in cancer-related fatigue using a validated Taiwanese version of the Brief Fatigue Inventory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hang Wang, PhD. | Hungkuang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital (NTUH) | Taipei | Taipei | 100229 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29138805 | Result | Lim JM, Lee YJ, Cho HR, Park DC, Jung GW, Ku SK, Choi JS. Extracellular polysaccharides purified from Aureobasidium pullulans SM-2001 (Polycan) inhibit dexamethasone-induced muscle atrophy in mice. Int J Mol Med. 2018 Mar;41(3):1245-1264. doi: 10.3892/ijmm.2017.3251. Epub 2017 Nov 10. | |
| 25120630 | Result | Choi JS, Kim JW, Kim KY, Cho HR, Choi IS, Ku SK. Antiosteoporotic effects of Polycan in combination with calcium lactate-gluconate in ovariectomized rats. Exp Ther Med. 2014 Sep;8(3):957-967. doi: 10.3892/etm.2014.1793. Epub 2014 Jun 20. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2025 |
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| Elastic Band Training | Behavioral | 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. |
|
| Baseline, Week 1, Week 2, Week 4, Week 8, Week 12 |
| Change in Quality of Life (EORTC QLQ-C30) | Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Assesses patient-reported physical, emotional, and social well-being. | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12 |
| Change in Inflammatory Markers: IL-6, CRP, TNF-α | 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. | Baseline, Week 4, Week 12 |
| Change in Mid-Upper Arm Circumference (MUAC) | Assesses changes in muscle mass via measurement of mid-upper arm circumference using the same standardized tape throughout the study. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Result | 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. |
| 28872611 | Result | Bashir KMI, Choi JS. Clinical and Physiological Perspectives of beta-Glucans: The Past, Present, and Future. Int J Mol Sci. 2017 Sep 5;18(9):1906. doi: 10.3390/ijms18091906. |
| 30956204 | Result | Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun. |
| 11568504 | Result | Shimomura Y, Obayashi M, Murakami T, Harris RA. Regulation of branched-chain amino acid catabolism: nutritional and hormonal regulation of activity and expression of the branched-chain alpha-keto acid dehydrogenase kinase. Curr Opin Clin Nutr Metab Care. 2001 Sep;4(5):419-23. doi: 10.1097/00075197-200109000-00013. |
| 4692853 | Result | Chou PY, Fasman GD. Structural and functional role of leucine residues in proteins. J Mol Biol. 1973 Mar 5;74(3):263-81. doi: 10.1016/0022-2836(73)90372-0. No abstract available. |
| 30485760 | Result | Neinast M, Murashige D, Arany Z. Branched Chain Amino Acids. Annu Rev Physiol. 2019 Feb 10;81:139-164. doi: 10.1146/annurev-physiol-020518-114455. Epub 2018 Nov 28. |
| 32230954 | Result | Martinez-Arnau FM, Fonfria-Vivas R, Buigues C, Castillo Y, Molina P, Hoogland AJ, van Doesburg F, Pruimboom L, Fernandez-Garrido J, Cauli O. Effects of Leucine Administration in Sarcopenia: A Randomized and Placebo-controlled Clinical Trial. Nutrients. 2020 Mar 27;12(4):932. doi: 10.3390/nu12040932. |
| 31250889 | Result | Fuchs CJ, Hermans WJH, Holwerda AM, Smeets JSJ, Senden JM, van Kranenburg J, Gijsen AP, Wodzig WKHW, Schierbeek H, Verdijk LB, van Loon LJC. Branched-chain amino acid and branched-chain ketoacid ingestion increases muscle protein synthesis rates in vivo in older adults: a double-blind, randomized trial. Am J Clin Nutr. 2019 Oct 1;110(4):862-872. doi: 10.1093/ajcn/nqz120. |
| Aug 16, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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