Improving Sarcopenia in Cancer Patients Undergoing Chemotherapy With High-Protein Nutritional Supplementation
NCT ID: NCT07114588
Last Updated: 2025-11-20
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
57 participants
INTERVENTIONAL
2025-01-23
2026-01-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nutritional Supplement + Elastic Band Training
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.
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.
Routine Care (Control Group)
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
No
Sponsors
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Ethan Nutraceutical Co., Ltd.
UNKNOWN
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hang Wang, PhD.
Role: PRINCIPAL_INVESTIGATOR
Hungkuang University
Locations
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National Taiwan University Hospital (NTUH)
Taipei, Taipei, Taiwan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202409133RIFE
Identifier Type: -
Identifier Source: org_study_id
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