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

Prince of Songkla University

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: standard formula supplement; Dietary Supplement: EPA-enriched supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02321631

REC 57-073-13-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 15 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups, including a placebo group

EPA-enriched supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: EPA-enriched supplement

standard formula supplement

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: standard formula supplement