Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

May 6, 2023 updated by: Aura Herrera, Maimónides Biomedical Research Institute of Córdoba

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • IMIBIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sarcopenia-Leucina1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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