Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients
June 4, 2013 updated by: Dental Innovation Foundation Under Royal Patronage
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- independent variable: continuous Nutri -jelly intake
- dependent variable (outcome): changes in health-related quality of life score
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Pathumthani, Thailand, 12110
- Mahavachiralongkorn cancer hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed as head and neck cancer
- definitive or palliative radiotherapy treatment plan
- can communicate well
Exclusion Criteria:
- bleeding in the mouth
- respiratory distress
- psychiatric disorders
- radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutri-jelly along with radiotherapy
Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy
|
an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement |
|
No Intervention: Radiotherapy only
Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Health-related quality of life score
Time Frame: 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
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0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Dunyaporn Trachootham, DDS, PhD, Faculty of Dentistry, Thammasat University, Thailand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 30, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 4, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIF-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.