Improving Sarcopenia in Cancer Patients Undergoing Chemotherapy With High-Protein Nutritional Supplementation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ETHANWELL BALANCED, Elastic Band Training.
- Who it may be relevant to
- Registry conditions: Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Sarcopenia During Chemotherapy
Overview
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 supplement 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. - Behavioral 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.
Primary outcome measures
- Improve hand grip strength (HGT) [Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
Secondary outcome measures (5)
- Improve body weight [Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
- Change in Brief Fatigue Inventory - Taiwanese version (BFI-T) Score [Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
- Change in Quality of Life (EORTC QLQ-C30) [Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12]
- Change in Inflammatory Markers: IL-6, CRP, TNF-α [Time frame: Baseline, Week 4, Week 12]
- Change in Mid-Upper Arm Circumference (MUAC) [Time frame: Baseline, Week 2, Week 4, Week 8, Week 12]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital (NTUH) — Taipei
Publications
- 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. PMID 29138805
- 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. PMID 25120630
- 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. PMID 28872611
- 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: 10.1 PMID 30956204
- 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. PMID 11568504
- 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. PMID 4692853
- 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. PMID 30485760
Identifiers
NCT: NCT07114588 · 202409133RIFE