NCT02321631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

December 4, 2014

Last Update Submit

March 2, 2020

Conditions

Head and Neck Cancer

Keywords

MalnourishedHead and Neck CancerSurgery

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Change from baseline in fat-free mass percentage at 3 weeks

    3 weeks

  • Change from baseline in fat-free mass percentage at 1 month

    1 month

  • Change from baseline in fat-free mass percentage at 3 months

    3 months

  • Change from baseline in body fat percentage at 3 weeks

    3 weeks

  • Change from baseline in body fat percentage at 1 month

    1 month

  • +1 more secondary outcomes

Study Arms (2)

EPA-enriched supplement

EXPERIMENTAL

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

standard formula supplement

PLACEBO COMPARATOR

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

Interventions

EPA-enriched supplementDIETARY_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.

EPA-enriched supplement
standard formula supplementDIETARY_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.

standard formula supplement

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as Head an Neck cancer with pathological confirmation
  • Receiving surgery as a primary treatment
  • Malnutrition screening tool(MST) is 2 or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kitti Jantharapattana, M.D.

    Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 22, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

TH(1)