Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
1 other identifier
interventional
64
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable head-and-neck-cancer
Started Jan 2012
Shorter than P25 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedJune 6, 2013
June 1, 2013
7 months
May 30, 2013
June 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Health-related quality of life score
* Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks * Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks
0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
Study Arms (2)
Nutri-jelly along with radiotherapy
EXPERIMENTALContinuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy
Radiotherapy only
NO INTERVENTIONReceive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly
Interventions
an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement
Eligibility Criteria
You may qualify if:
- diagnosed as head and neck cancer
- definitive or palliative radiotherapy treatment plan
- can communicate well
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dental Innovation Foundation Under Royal Patronagelead
- Thammasat Universitycollaborator
- Srinakharinwirot Universitycollaborator
- Mahidol Universitycollaborator
- Ministry of Health, Thailandcollaborator
Study Sites (1)
Mahavachiralongkorn cancer hospital
Pathum Thani, Changwat Pathum Thani, 12110, Thailand
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dunyaporn Trachootham, DDS, PhD
Faculty of Dentistry, Thammasat University, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 6, 2013
Study Start
January 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
June 6, 2013
Record last verified: 2013-06