Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Not Applicable

Completed

• Conditions: Cancer; Sarcopenia
• Interventions: Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement; Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

• Registration Number: NCT05837741
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.

Detailed Description

Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-11-01
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-19
• Status Verified: 2023-05
• Study First Posted: 2023-05-01
• Last Update Submitted: 2023-05-06
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• patients of both sexes, age > 18 y-old
• cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
• weight loss >5% during the previous three months or >10% during the previous six months

Exclusion Criteria

• end-stage kidney disease
• life expectancy < 2 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard hypercaloric, hyperproteic oral supplement	Standard hypercaloric hyperproteic oral nutritional supplement	Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)
Leucin-enriched hypercaloric, hyperproteic oral supplement	Leucine-enriched hypercaloric hyperproteic oral nutritional supplement	Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)

Primary Outcome Measures

Name	Time	Method
Muscle mass gain	3 Months	Changes in Muscle mass (%) determined by BIA and echography

Secondary Outcome Measures

Name	Time	Method
Changes in prealbumin	3 Months	Changes in serum prealbumin levels (mg/dL)
Changes in albumin	3 Months	Changes in serum albumin levels (g/dL)
Fat mass change	3 Months	Changes in fast mass (%) determined by BIA and echography
Phase angle change	3 Months	Changes in phase angle determined by BIA
Changes in CRP	3 Months	Changes in serum CRP levels (g/L)

Trial Locations

Locations (1)

IMIBIC; 🇪🇸 Córdoba, Cordoba, Spain