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A single-arm study of oral nutritional supplementation with beta-hydroxy-beta-methylbutyric acid to improve the incidence of sarcopenia in patients with primary advanced first-line colorectal cancer

A single-arm study of oral nutritional supplementation with beta-hydroxy-beta-methylbutyric acid to improve the incidence of sarcopenia in patients with primary advanced first-line colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103189
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Intervention group:Oral nutritional supplement ß-hydroxy-ß-methylbutyric acid

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with primary advanced first-line colorectal cancer aged 18 years or older and less than 75 years old, who are proposed to be treated with the Xelox regimen; 2. no galactosemia, abnormalities in amino acid metabolism, or allergies to milk or soy proteins; 3. NRS-2002 >= 3, PG-SGA >= 9, and an ECOG score of <= 2; 4. life expectancy of more than 6 months; 5. tolerate enteral nutrition or receive more than 5 consecutive days of treatment; 6, patients agree to participate in this study with voluntary informed consent. Receive parenteral nutrition for no more than 5 consecutive days; 6. Patients have civil capacity, agree to participate in this study and voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1Patients who cannot tolerate enteral nutrition; if patients need parenteral nutrition intervention after dietitian's assessment in the course of treatment, it is necessary to record the use and duration of such intervention in the record of the course of disease, and the duration of each use of parenteral nutrition shall not be more than 5 consecutive days, and at the same time, the cleaning period shall be set up. The length of the cleansing period shall be adjusted according to the patient's liver and kidney functions. If the indicators of liver and kidney functions such as aspartate aminotransferase and alanine aminotransferase, creatinine and urea are not more than 5 times of the normal value, the cleansing period shall be 3 days; if any of the above indicators is more than 5 times of the normal value, the cleansing period shall be 7 days. 2, patients who are not suitable for body composition analysis examination, such as the presence of metal substances in the body, such as internal fixators, pacemakers, etc. may affect the results of the subjects; 3, subjects who are taking appetite-enhancing drugs (such as medroxyprogesterone tablets or corticosteroid analogues) or who have a history of allergy to or intolerance of HMB, etc.; 4, patients who are unable to tolerate chemotherapeutic treatments; 5, pregnant or breastfeeding female patients; 6, Patients who, in the opinion of the investigator, are not suitable for enrolment such as those with any severe or uncontrolled systemic disease, including uncontrolled diabetes mellitus, hypertension, hepatitis, and human immunodeficiency virus, that may significantly affect the risk/benefit balance of the patient, or patients with poor adherence.

Design outcomes

Primary

MeasureTime frame
Sarcopenia score;L3-skeletal muscle index, L3-SMI;Nutritional status;

Secondary

MeasureTime frame
Hand Grip Strength;Body composition analysis;Gut microbiota;

Countries

China

Contacts

Public ContactLuyi zhangbo

Zhejiang Cancer Hospital

luyi@zjcc.org.cn+86 135 8831 6980

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026