Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
omega-3
Standard
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring cancer, nutritional support, omega-3 enriched nutritional supplements
Eligibility Criteria
Inclusion Criteria: - Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination) Body weight loss >5% in the previous three months or >10% in the previous six months Both sexes Age between 18-85 y-old. Exclusion Criteria: Life expectancy < 2 weeks MDRD < 15 mL/min End-stage liver disease Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Sites / Locations
- IMIBICRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard hypercaloric, hyperproteic oral supplement
omega-3 enriched oral supplement
Arm Description
Outcomes
Primary Outcome Measures
Muscle mass
Muscle mass change (in Kg)
Functionality
Changes in functionality measured with the Up and Go Test
Secondary Outcome Measures
Albumin
Changes in serum albumin levels (g/dl)
C-RP
Changes in serum C-RP(g/dl)
Full Information
NCT ID
NCT06015971
First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT06015971
Brief Title
Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
Official Title
Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
cancer, nutritional support, omega-3 enriched nutritional supplements
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard hypercaloric, hyperproteic oral supplement
Arm Type
Active Comparator
Arm Title
omega-3 enriched oral supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3
Intervention Description
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard
Intervention Description
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
Primary Outcome Measure Information:
Title
Muscle mass
Description
Muscle mass change (in Kg)
Time Frame
12 weeks
Title
Functionality
Description
Changes in functionality measured with the Up and Go Test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Albumin
Description
Changes in serum albumin levels (g/dl)
Time Frame
12 weeks
Title
C-RP
Description
Changes in serum C-RP(g/dl)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
Body weight loss >5% in the previous three months or >10% in the previous six months
Both sexes
Age between 18-85 y-old.
Exclusion Criteria:
Life expectancy < 2 weeks
MDRD < 15 mL/min
End-stage liver disease
Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Facility Information:
Facility Name
IMIBIC
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Carlos Garrido, PhD
Phone
957 213831
Email
josecarlos.garrido@imibic.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
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