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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321631

Enrollment

Registered

2014-12-22

Start date

2015-01-31

Completion date

2018-03-31

Last updated

2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Malnourished, Head and Neck Cancer, Surgery

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTEPA-enriched 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.

DIETARY_SUPPLEMENTstandard formula 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Body weight at 3 weeks	3 weeks	Body weight measured in kilogram
Change from baseline in Body weight at 1 month	1 month	Body weight measured in kilogram
Change from baseline in Body weight at 3 months	3 months	Body weight measured in kilogram

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026