Skip to main content
OpenTrials
Completed

NCT Number: NCT01871155

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahavachiralongkorn cancer hospital

Pathum Thani, Changwat Pathum Thani, 12110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutri-jelly

Dietary Supplement

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dental Innovation Foundation Under Royal Patronage

Other

Collaborators

  • Mahidol University
  • Ministry of Health, Thailand
  • Srinakharinwirot University
  • Thammasat University

Registry information

Official study title

Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2013
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.