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NCT Number: NCT02321631

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline in Body weight at 3 weeks

    Time frame: 3 weeks

    Body weight measured in kilogram

  2. Change from baseline in Body weight at 1 month

    Time frame: 1 month

    Body weight measured in kilogram

  3. Change from baseline in Body weight at 3 months

    Time frame: 3 months

    Body weight measured in kilogram

Secondary outcomes

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

    Time frame: 3 weeks

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

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

    Time frame: 1 month

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

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

    Time frame: 3 months

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

  4. Change from baseline in body fat percentage at 3 weeks

    Time frame: 3 weeks

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

  5. Change from baseline in body fat percentage at 1 month

    Time frame: 1 month

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

  6. Change from baseline in body fat percentage at 3 months

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2014
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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