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OpenTrials
Completed

NCT Number: NCT05837741

Leucine-enriched Formulas in Patients With Tumor-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.

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Key information

Conditions

Sarcopenia Atrophy Cancer Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMIBIC

Córdoba, Cordoba, 14004, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard hypercaloric hyperproteic oral nutritional supplement

Dietary Supplement

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

Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Dietary Supplement

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

Primary outcomes

  1. Muscle mass gain

    Time frame: 3 Months

    Changes in Muscle mass (%) determined by BIA and echography

Secondary outcomes

  1. Fat mass change

    Time frame: 3 Months

    Changes in fast mass (%) determined by BIA and echography

  2. Phase angle change

    Time frame: 3 Months

    Changes in phase angle determined by BIA

  3. Changes in albumin

    Time frame: 3 Months

    Changes in serum albumin levels (g/dL)

  4. Changes in prealbumin

    Time frame: 3 Months

    Changes in serum prealbumin levels (mg/dL)

  5. Changes in CRP

    Time frame: 3 Months

    Changes in serum CRP levels (g/L)

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 1, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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