Clinical Trials Logo
  1. Home
  2. Cancer
  3. NCT05837741
  4. Details
NCT05837741 Clinical Trial

Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05837741
Other study ID # Sarcopenia-Leucina1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date November 1, 2021

Study information
Verified date May 2023
Source Maimónides Biomedical Research Institute of Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Standard hypercaloric hyperproteic oral nutritional supplement
Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement
• Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Locations
Country Name City State
Spain IMIBIC Córdoba Cordoba

Sponsors (1)
Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Muscle mass gain Changes in Muscle mass (%) determined by BIA and echography 3 Months
Secondary Fat mass change Changes in fast mass (%) determined by BIA and echography 3 Months
Secondary Phase angle change Changes in phase angle determined by BIA 3 Months
Secondary Changes in albumin Changes in serum albumin levels (g/dL) 3 Months
Secondary Changes in prealbumin Changes in serum prealbumin levels (mg/dL) 3 Months
Secondary Changes in CRP Changes in serum CRP levels (g/L) 3 Months
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases