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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: EPA-enriched supplement; Dietary supplement: standard formula supplement

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary 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.
PLACEBO_COMPARATOR: 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.	Dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Body weight at 3 weeks	Body weight measured in kilogram	3 weeks
Change from baseline in Body weight at 1 month	Body weight measured in kilogram	1 month
Change from baseline in Body weight at 3 months	Body weight measured in kilogram	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in fat-free mass percentage at 3 weeks	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	3 weeks
Change from baseline in fat-free mass percentage at 1 month	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	1 month
Change from baseline in fat-free mass percentage at 3 months	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	3 months
Change from baseline in body fat percentage at 3 weeks	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	3 weeks
Change from baseline in body fat percentage at 1 month	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	1 month
Change from baseline in body fat percentage at 3 months	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	3 months

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Kitti Jantharapattana, M.D., Faculty of Medicine, Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (ESTIMATE): December 22, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Surgery; Malnourished
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Nutrition Disorders; Head and Neck Neoplasms; Malnutrition
• Other Study ID Numbers: REC 57-073-13-1