Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Cancer; Sarcopenia

Treatments: Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement; Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05837741

Sarcopenia-Leucina1

Details and patient eligibility

About

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

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Standard hypercaloric, hyperproteic oral supplement

Active Comparator group

Description:

Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)

Treatment:

Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement

Leucin-enriched hypercaloric, hyperproteic oral supplement

Active Comparator group

Description:

Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)

Treatment:

Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement