Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05837741

Enrollment

Registered

2023-05-01

Start date

2021-03-01

Completion date

2021-11-01

Last updated

2023-05-09

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

Conditions

Cancer, Sarcopenia

Keywords

Sarcopenia, Cancer

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

Interventions

DIETARY_SUPPLEMENTStandard hypercaloric hyperproteic oral nutritional supplement

Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement

DIETARY_SUPPLEMENTLeucine-enriched hypercaloric hyperproteic oral nutritional supplement

Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Muscle mass gain	3 Months	Changes in Muscle mass (%) determined by BIA and echography

Secondary

Measure	Time frame	Description
Changes in prealbumin	3 Months	Changes in serum prealbumin levels (mg/dL)
Changes in CRP	3 Months	Changes in serum CRP levels (g/L)
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 albumin	3 Months	Changes in serum albumin levels (g/dL)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026