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

Not Applicable

Completed

• Conditions: Head and Neck Cancer

• 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

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

Prince of Songkla University

🇹🇭Hatyai, Songkhla, Thailand