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

Prince of Songkla University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

EPA-enriched supplementDIETARY_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.

standard formula supplementDIETARY_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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients diagnosed as Head an Neck cancer with pathological confirmation 2. Receiving surgery as a primary treatment 3. Malnutrition screening tool(MST) is 2 or more Exclusion Criteria: 1. Previously irradiated patient in the Head and Neck region 2. Previously receiving chemotherapy 3. Renal insufficiency with serum creatinine \> 2.5 mg/dL 4. Liver function abnormality with total serum bilirubin \> 3.0 mg/dL 5. Pregnancy

Locations (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

Change from baseline in Body weight at 3 weeks

Body weight measured in kilogram

Time frame: 3 weeks

Change from baseline in Body weight at 1 month

Body weight measured in kilogram

Time frame: 1 month

Change from baseline in Body weight at 3 months

Body weight measured in kilogram

Time frame: 3 months

Secondary Outcomes

Change from baseline in fat-free mass percentage at 3 weeks

Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

Time frame: 3 weeks

Change from baseline in fat-free mass percentage at 1 month

Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

Time frame: 1 month

Change from baseline in fat-free mass percentage at 3 months

Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

Time frame: 3 months

Change from baseline in body fat percentage at 3 weeks

Percent of body fat on the Bioelectrical Impedance Analysis (BIA)

Time frame: 3 weeks

Change from baseline in body fat percentage at 1 month

Percent of body fat on the Bioelectrical Impedance Analysis (BIA)

Time frame: 1 month

Data from ClinicalTrials.gov

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