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

NCT07114588 | Enrolling By Invitation

• 1 other identifier: 202409133RIFE
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy

Keywords

Sarcopenia; Cancer; Chemotherapy; Nutritional Supplement; ETHANWELL BALANCED; Muscle Strength; BCAA; Beta-glucan; Protein Intake; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Change in Quality of Life (EORTC QLQ-C30)

  Baseline, Week 1, Week 2, Week 4, Week 8, Week 12

• Change in Inflammatory Markers: IL-6, CRP, TNF-α

  Baseline, Week 4, Week 12

• Change in Mid-Upper Arm Circumference (MUAC)

  Baseline, Week 2, Week 4, Week 8, Week 12

Study Arms (2)

Nutritional Supplement + Elastic Band Training

EXPERIMENTAL

Dietary Supplement: ETHANWELL BALANCED; Behavioral: Elastic Band Training

Routine Care (Control Group)

NO INTERVENTION

Interventions

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.

Nutritional Supplement + Elastic Band Training

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.

Nutritional Supplement + Elastic Band Training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ethan Nutraceutical Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital (NTUH)

Taipei, Taipei, 100229, Taiwan

Location

Related Publications (10)

• 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 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.

  PMID: 25120630 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.

  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.

  PMID: 28872611 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.

  PMID: 30956204 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.

  PMID: 11568504 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.

  PMID: 4692853 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.

  PMID: 30485760 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.

  PMID: 32230954 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.

  PMID: 31250889 RESULT

MeSH Terms

Conditions

Sarcopenia; Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Hang Wang, PhD.

  Hungkuang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: January 23, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)