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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA-enriched supplement | Experimental | 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. |
|
| standard formula supplement | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA-enriched supplement | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kitti Jantharapattana, M.D. | Faculty of Medicine, Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| standard formula supplement | Dietary Supplement | 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. |
|
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 |