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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321631
• Other study ID #: REC 57-073-13-1
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2020
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Malnutrition

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Body weight at 3 weeks	Body weight measured in kilogram	3 weeks
Primary	Change from baseline in Body weight at 1 month	Body weight measured in kilogram	1 month
Primary	Change from baseline in Body weight at 3 months	Body weight measured in kilogram	3 months
Secondary	Change from baseline in fat-free mass percentage at 3 weeks	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	3 weeks
Secondary	Change from baseline in fat-free mass percentage at 1 month	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	1 month
Secondary	Change from baseline in fat-free mass percentage at 3 months	Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)	3 months
Secondary	Change from baseline in body fat percentage at 3 weeks	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	3 weeks
Secondary	Change from baseline in body fat percentage at 1 month	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	1 month
Secondary	Change from baseline in body fat percentage at 3 months	Percent of body fat on the Bioelectrical Impedance Analysis (BIA)	3 months