Back to resultsLeucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
Primary Purpose
Sarcopenia, Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard hypercaloric hyperproteic oral nutritional supplement
Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring Sarcopenia, Cancer
Eligibility Criteria
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
Sites / Locations
- IMIBIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard hypercaloric, hyperproteic oral supplement
Leucin-enriched hypercaloric, hyperproteic oral supplement
Arm Description
Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)
Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)
Outcomes
Primary Outcome Measures
Muscle mass gain
Changes in Muscle mass (%) determined by BIA and echography
Secondary Outcome Measures
Fat mass change
Changes in fast mass (%) determined by BIA and echography
Phase angle change
Changes in phase angle determined by BIA
Changes in albumin
Changes in serum albumin levels (g/dL)
Changes in prealbumin
Changes in serum prealbumin levels (mg/dL)
Changes in CRP
Changes in serum CRP levels (g/L)
Full Information
NCT ID
NCT05837741
First Posted
April 1, 2023
Last Updated
May 6, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT05837741
Brief Title
Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
Official Title
Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Cancer
Keywords
Sarcopenia, Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard hypercaloric, hyperproteic oral supplement
Arm Type
Active Comparator
Arm Description
Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)
Arm Title
Leucin-enriched hypercaloric, hyperproteic oral supplement
Arm Type
Active Comparator
Arm Description
Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard hypercaloric hyperproteic oral nutritional supplement
Intervention Description
Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Intervention Description
Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Primary Outcome Measure Information:
Title
Muscle mass gain
Description
Changes in Muscle mass (%) determined by BIA and echography
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Fat mass change
Description
Changes in fast mass (%) determined by BIA and echography
Time Frame
3 Months
Title
Phase angle change
Description
Changes in phase angle determined by BIA
Time Frame
3 Months
Title
Changes in albumin
Description
Changes in serum albumin levels (g/dL)
Time Frame
3 Months
Title
Changes in prealbumin
Description
Changes in serum prealbumin levels (mg/dL)
Time Frame
3 Months
Title
Changes in CRP
Description
Changes in serum CRP levels (g/L)
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aura D Herrera Martinez, PhD
Organizational Affiliation
IMIBIC-HURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMIBIC
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
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