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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Dietary Supplement: EPA-enriched supplement; Dietary Supplement: standard formula supplement

• Registration Number: NCT02321631
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Study Start: 2015-01
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA-enriched supplement	EPA-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.
standard formula supplement	standard 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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 body fat percentage at 1 month	1 month	Percent of body fat 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)

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hatyai, Songkhla, Thailand