Efficacy of EPA-enriched Supplement in Malnourished Head and Neck Cancer Patients Undergone Surgery

Study Overview
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Brief Summary
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The purpose of this study is to study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. Primary outcome is perioperative weight changing.

Detailed Description
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To study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. The patients are divided into 2 groups receiving the different formula supplements. The both supplements are isocaloric. The patients receive the supplement for 3 weeks (1 week prior to surgery and 2 weeks post surgery) Primary outcome is perioperative weight changing. Secondary outcomes are body compositions, hospital stay days, complication and co-morbidity.

Official Title
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Efficacy of EPA-enriched Supplement Compared With Standard Formula on Body Weight Changing in Malnourished Head and Neck Cancer Patients Undergone Surgery: A Randomized Study

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: EPA-enriched supplement
* Dietary Supplement: standard formula supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as Head an Neck cancer with pathological confirmation Receiving surgery as a primary treatment Malnutrition screening tool(MST) is 2 or more Exclusion Criteria: Previously irradiated patient in the Head and Neck region Previously receiving chemotherapy Renal insufficiency with serum creatinine > 2.5 mg/dL Liver function abnormality with total serum bilirubin > 3.0 mg/dL Pregnancy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA-enriched supplement<br>EPA-enriched supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement composes of 2.2 gm of EPA and 630 kcal daily. | Dietary Supplement: EPA-enriched supplement<br>* EPA-enriched supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement composes of 2.2 gm of EPA and 630 kcal daily.<br>|
| Placebo Comparator: standard formula supplement<br>The standard formula supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement is 630 kcal daily without EPA. | Dietary Supplement: standard formula supplement<br>* The standard formula supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement is 630 kcal daily without EPA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Body weight at 3 weeks | Body weight measured in kilogram | 3 weeks | 
| Change from baseline in Body weight at 1 month | Body weight measured in kilogram | 1 month | 
| Change from baseline in Body weight at 3 months | Body weight measured in kilogram | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fat-free mass percentage at 3 weeks | Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA) | 3 weeks | 
| Change from baseline in fat-free mass percentage at 1 month | Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA) | 1 month | 
| Change from baseline in fat-free mass percentage at 3 months | Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA) | 3 months | 
| Change from baseline in body fat percentage at 3 weeks | Percent of body fat on the Bioelectrical Impedance Analysis (BIA) | 3 weeks | 
| Change from baseline in body fat percentage at 1 month | Percent of body fat on the Bioelectrical Impedance Analysis (BIA) | 1 month | 
| Change from baseline in body fat percentage at 3 months | Percent of body fat on the Bioelectrical Impedance Analysis (BIA) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnourished, Head and Neck Cancer, Surgery