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

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ClinicalTrials.gov Identifier: NCT02321631
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Kitti Jantharapattana, M.D., Prince of Songkla University

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dietary Supplement: EPA-enriched supplement Dietary Supplement: standard formula supplement Phase 3

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline in Body weight at 3 weeks [ Time Frame: 3 weeks ]
    Body weight measured in kilogram

  2. Change from baseline in Body weight at 1 month [ Time Frame: 1 month ]
    Body weight measured in kilogram

  3. Change from baseline in Body weight at 3 months [ Time Frame: 3 months ]
    Body weight measured in kilogram


Secondary Outcome Measures :
  1. Change from baseline in fat-free mass percentage at 3 weeks [ Time Frame: 3 weeks ]
    Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

  2. Change from baseline in fat-free mass percentage at 1 month [ Time Frame: 1 month ]
    Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

  3. Change from baseline in fat-free mass percentage at 3 months [ Time Frame: 3 months ]
    Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)

  4. Change from baseline in body fat percentage at 3 weeks [ Time Frame: 3 weeks ]
    Percent of body fat on the Bioelectrical Impedance Analysis (BIA)

  5. Change from baseline in body fat percentage at 1 month [ Time Frame: 1 month ]
    Percent of body fat on the Bioelectrical Impedance Analysis (BIA)

  6. Change from baseline in body fat percentage at 3 months [ Time Frame: 3 months ]
    Percent of body fat on the Bioelectrical Impedance Analysis (BIA)



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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321631


Contacts
Contact: Kitti Jantharapattana, M.D. (66)074451390 kittient@hotmail.com
Contact: Orachat Orapiphatpong, M.D. (66)074451390 filidius@hotmail.com

Locations
Thailand
Prince of Songkla University Recruiting
Hatyai, Songkhla, Thailand, 90110
Contact: Kitti Jantharapattana, M.D.    66074451390    kittient@hotmail.com   
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Kitti Jantharapattana, M.D. Faculty of Medicine, Prince of Songkla University

Responsible Party: Kitti Jantharapattana, M.D., Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02321631     History of Changes
Other Study ID Numbers: REC 57-073-13-1
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Kitti Jantharapattana, M.D., Prince of Songkla University:
Malnourished
Head and Neck Cancer
Surgery

Additional relevant MeSH terms:
Head and Neck Neoplasms
Malnutrition
Neoplasms by Site
Neoplasms
Nutrition Disorders