Early-stage Sarcopenia in Adult Cancer Patients Undergoing ChemotherapyNCT07114588
Improving Sarcopenia in Cancer Patients Undergoing Chemotherapy With High-Protein Nutritional Supplementation
A study testing ETHANWELL BALANCED and Elastic Band Training in people with Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy
- What is being tested?
- ETHANWELL BALANCED and Elastic Band Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2025to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Poorly controlled diabetes diagnosed by a physician.
- End-stage renal disease-requiring hemodialysis or peritoneal dialysis.
- Liver cirrhosis with severe ascites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Sarcopenia During Chemotherapy
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.
Read the 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.
- Being tested
- ETHANWELL BALANCED, Elastic Band Training
- Keywords
- Sarcopenia; Cancer; Chemotherapy; Nutritional Supplement; ETHANWELL BALANCED; Muscle Strength; BCAA; Beta-glucan; Protein Intake; Fatigue
- Medical subject headings
- Sarcopenia, Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETHANWELL BALANCEDDietary 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.
Elastic Band TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement + Elastic Band Training | Experimental | Not described Receives: Dietary Supplement: ETHANWELL BALANCED; Behavioral: Elastic Band Training |
| Routine Care (Control Group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve hand grip strength (HGT)
Measured using an electronic hand dynamometer. Assesses change in muscle strength over the course of 12-week intervention.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12
Secondary outcomes (5)
Improve body weight
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start23 Jan 2025
- Primary completion22 Jan 2026 (estimated)
- Study completion22 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Early-stage Sarcopenia in Adult Cancer Patients Undergoing ChemotherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ethan Nutraceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hang Wang, PhD., Principal investigator, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114588
- Sponsor's protocol ID
- 202409133RIFE
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29138805Choi 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.
PubMed 25120630Preventing 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.
PubMed 28872611Laveneziana 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.
PubMed 30956204Shimomura 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.
PubMed 11568504Chou 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.
PubMed 4692853Neinast 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.
PubMed 30485760Martinez-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.
PubMed 32230954Fuchs 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.
PubMed 31250889
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sarcopenia During Chemotherapy
- ClinicalTrials.gov ID
- NCT07114588
- Acronym / sponsor ID
- 202409133RIFE
- Keywords
- Sarcopenia; Cancer; Chemotherapy; Nutritional Supplement; ETHANWELL BALANCED; Muscle Strength; BCAA; Beta-glucan; Protein Intake; Fatigue
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ethan Nutraceutical Co., Ltd.
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 22 Jan 2026 (estimated)
- Study completion
- 22 Jan 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement + Elastic Band Training | Experimental | Dietary Supplement: ETHANWELL BALANCED, Behavioral: Elastic Band Training |
| Routine Care (Control Group) | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETHANWELL BALANCEDA 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. | Dietary supplement | Nutritional Supplement + Elastic Band Training |
| Elastic Band TrainingParticipants 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. | Behavioural | Nutritional Supplement + Elastic Band Training |
Primary outcome
Improve hand grip strength (HGT)
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 29138805Lim 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.
- Results publication: PubMed 25120630Choi 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.
- Results publicationPreventing 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.
- Results publication: PubMed 28872611Bashir 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.
- Results publication: PubMed 30956204Laveneziana 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.
- Results publication: PubMed 11568504Shimomura 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.
- Results publication: PubMed 4692853Chou 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.
- Results publication: PubMed 30485760Neinast 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.
- Results publication: PubMed 32230954Martinez-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.
- Results publication: PubMed 31250889Fuchs 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hang Wang, PhD. principal investigator
Hungkuang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETHANWELL BALANCED and Elastic Band Training in people with Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve hand grip strength (HGT) (time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114588, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.