Head and Neck CancerNCT02321631
Efficacy of EPA-enriched Supplement in Malnourished Head and Neck Cancer Patients Undergone Surgery
A study testing EPA-enriched supplement and standard formula supplement in people with Head and Neck Cancer, run by Prince of Songkla University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- EPA-enriched supplement and standard formula supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed as Head an Neck cancer with pathological confirmation
- Receiving surgery as a primary treatment
- Malnutrition screening tool(MST) is 2 or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- EPA-enriched supplement, standard formula supplement
- Keywords
- Malnourished, Head and Neck Cancer, Surgery
- Medical subject headings
- Head and Neck Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: standard formula supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Body weight at 3 weeks
Body weight measured in kilogram
Measured: 3 weeks
Change from baseline in Body weight at 1 month
Body weight measured in kilogram
Measured: 1 month
Change from baseline in Body weight at 3 months
Body weight measured in kilogram
Measured: 3 months
Secondary outcomes (6)
Change from baseline in fat-free mass percentage at 3 weeks
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Measured: 3 weeks
Change from baseline in fat-free mass percentage at 1 month
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Measured: 1 month
Change from baseline in fat-free mass percentage at 3 months
Percent of fat-free mass on the Bioelectrical Impedance Analysis (BIA)
Measured: 3 months
Change from baseline in body fat percentage at 3 weeks
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Measured: 3 weeks
Change from baseline in body fat percentage at 1 month
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Measured: 1 month
Change from baseline in body fat percentage at 3 months
Percent of body fat on the Bioelectrical Impedance Analysis (BIA)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kitti Jantharapattana, M.D., Prince of Songkla University
- Investigators
- Kitti Jantharapattana, M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321631
- Sponsor's protocol ID
- REC 57-073-13-1
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2014
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02321631
- Acronym / sponsor ID
- REC 57-073-13-1
- Conditions
- Head and Neck Cancer
- Keywords
- Malnourished, Head and Neck Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA-enriched supplement | Experimental | Dietary Supplement: EPA-enriched supplementEPA-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 | Placebo comparator | Dietary Supplement: standard formula supplementThe 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. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed as Head an Neck cancer with pathological confirmation
- Receiving surgery as a primary treatment
- Malnutrition screening tool(MST) is 2 or more
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPA-enriched supplementEPA-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 supplementThe 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 |
Primary outcome
Change from baseline in Body weight at 3 weeks
Time frame: 3 weeks
Body weight measured in kilogram
Change from baseline in Body weight at 1 month
Time frame: 1 month
Body weight measured in kilogram
Change from baseline in Body weight at 3 months
Time frame: 3 months
Body weight measured in kilogram
6 secondary outcomes
Change from baseline in fat-free mass percentage at 3 weeks
Time frame: 3 weeks
Change from baseline in fat-free mass percentage at 1 month
Time frame: 1 month
Change from baseline in fat-free mass percentage at 3 months
Time frame: 3 months
Change from baseline in body fat percentage at 3 weeks
Time frame: 3 weeks
Change from baseline in body fat percentage at 1 month
Time frame: 1 month
Change from baseline in body fat percentage at 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kitti Jantharapattana, M.D. principal investigator
Faculty of Medicine, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA-enriched supplement and standard formula supplement in people with Head and Neck Cancer, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Body weight at 3 weeks (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.