Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

NCT ID: NCT05837741

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-11-01

Brief Summary

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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

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

Conditions

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Sarcopenia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard hypercaloric, hyperproteic oral supplement

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

Group Type ACTIVE_COMPARATOR

Standard hypercaloric hyperproteic oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

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

Leucin-enriched hypercaloric, hyperproteic oral supplement

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

Group Type ACTIVE_COMPARATOR

Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Standard hypercaloric hyperproteic oral nutritional supplement

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

Intervention Type DIETARY_SUPPLEMENT

Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Aura Herrera

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aura D Herrera Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

IMIBIC-HURS

Locations

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IMIBIC

Córdoba, Cordoba, Spain

Site Status

Countries

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Spain

Other Identifiers

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Sarcopenia-Leucina1

Identifier Type: -

Identifier Source: org_study_id

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