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

P

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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