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Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Nutri-jelly
Sponsored by
Dental Innovation Foundation Under Royal Patronage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mahavachiralongkorn cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutri-jelly along with radiotherapy

Radiotherapy only

Arm Description

Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy

Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 30, 2013
Last Updated
June 4, 2013
Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01871155
Brief Title
Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients
Official Title
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
independent variable: continuous Nutri -jelly intake dependent variable (outcome): changes in health-related quality of life score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Dysphagia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutri-jelly along with radiotherapy
Arm Type
Experimental
Arm Description
Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy
Arm Title
Radiotherapy only
Arm Type
No Intervention
Arm Description
Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutri-jelly
Intervention Description
an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement
Primary Outcome Measure Information:
Title
Changes in Health-related quality of life score
Description
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
Time Frame
0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunyaporn Trachootham, DDS, PhD
Organizational Affiliation
Faculty of Dentistry, Thammasat University, Thailand
Official's Role
Study Chair
Facility Information:
Facility Name
Mahavachiralongkorn cancer hospital
City
Pathumthani
ZIP/Postal Code
12110
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.dent-in-found.org/
Description
Dental Innovation Foundation under royal patronage, His Majesty the King's dental service unit

Learn more about this trial

Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients

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