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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
EPA-enriched supplement
standard formula supplement
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Malnourished, Head and Neck Cancer, Surgery

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EPA-enriched supplement

standard formula supplement

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Body weight at 3 weeks
Body weight measured in kilogram
Change from baseline in Body weight at 1 month
Body weight measured in kilogram
Change from baseline in Body weight at 3 months
Body weight measured in kilogram

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2014
Last Updated
March 2, 2020
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT02321631
Brief Title
Efficacy of EPA-enriched Supplement in Malnourished Head and Neck Cancer Patients Undergone Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Malnourished, Head and Neck Cancer, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPA-enriched supplement
Arm Type
Experimental
Arm 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.
Arm Title
standard formula supplement
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA-enriched supplement
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
standard formula supplement
Intervention 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.
Primary Outcome Measure Information:
Title
Change from baseline in Body weight at 3 weeks
Description
Body weight measured in kilogram
Time Frame
3 weeks
Title
Change from baseline in Body weight at 1 month
Description
Body weight measured in kilogram
Time Frame
1 month
Title
Change from baseline in Body weight at 3 months
Description
Body weight measured in kilogram
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline in fat-free mass percentage at 3 weeks
Description
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Time Frame
3 weeks
Title
Change from baseline in fat-free mass percentage at 1 month
Description
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Time Frame
1 month
Title
Change from baseline in fat-free mass percentage at 3 months
Description
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Time Frame
3 months
Title
Change from baseline in body fat percentage at 3 weeks
Description
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Time Frame
3 weeks
Title
Change from baseline in body fat percentage at 1 month
Description
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Time Frame
1 month
Title
Change from baseline in body fat percentage at 3 months
Description
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as Head an Neck cancer with pathological confirmation Receiving surgery as a primary treatment Malnutrition screening tool(MST) is 2 or more Exclusion Criteria: Previously irradiated patient in the Head and Neck region Previously receiving chemotherapy Renal insufficiency with serum creatinine > 2.5 mg/dL Liver function abnormality with total serum bilirubin > 3.0 mg/dL Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kitti Jantharapattana, M.D.
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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

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