Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Completed

CT.gov ID

NCT05837741

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Cancer	Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard hypercaloric, hyperproteic oral supplement Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)	Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement
Active Comparator: Leucin-enriched hypercaloric, hyperproteic oral supplement Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)	Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Arm

Intervention/Treatment

Active Comparator: Standard hypercaloric, hyperproteic oral supplement

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

Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement

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

Active Comparator: Leucin-enriched hypercaloric, hyperproteic oral supplement

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

Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

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

Outcome Measures

Primary Outcome Measures

Muscle mass gain [3 Months]
Changes in Muscle mass (%) determined by BIA and echography

Secondary Outcome Measures

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)
Changes in prealbumin [3 Months]
Changes in serum prealbumin levels (mg/dL)
Changes in CRP [3 Months]
Changes in serum CRP levels (g/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IMIBIC	Córdoba	Cordoba	Spain	14004

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba

Investigators

Principal Investigator: Aura D Herrera Martinez, PhD, IMIBIC-HURS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aura Herrera, MD, MSc, PhD, Maimónides Biomedical Research Institute of Córdoba

ClinicalTrials.gov Identifier:

NCT05837741

Other Study ID Numbers:

Sarcopenia-Leucina1

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aura Herrera, MD, MSc, PhD, Maimónides Biomedical Research Institute of Córdoba

Sarcopenia

Cancer

Additional relevant MeSH terms:

Sarcopenia

Study Results

No Results Posted as of May 1, 2023