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

  • Thailand
      • Pathumthani, Thailand, 12110
        • Mahavachiralongkorn cancer hospital

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
Dietary supplement: Nutri-jelly

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
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dental Innovation Foundation Under Royal Patronage

Collaborators

Mahidol University
Ministry of Health, Thailand
Thammasat University
Srinakharinwirot University

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.

Helpful Links

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.

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