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

National Taiwan University

Status

Invitation-only

Conditions

Early-stage Sarcopenia in Adult Cancer Patients Undergoing Chemotherapy

Treatments

Dietary Supplement: ETHANWELL BALANCED

Behavioral: Elastic Band Training

Study type

Interventional

Funder types

Other

Identifiers

NCT07114588

202409133RIFE

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.