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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Dysphagia
• Interventions: Dietary Supplement: Nutri-jelly

• Registration Number: NCT01871155
• Lead Sponsor: Dental Innovation Foundation Under Royal Patronage

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

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2013-05-30
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-06
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutri-jelly along with radiotherapy	Nutri-jelly	Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy

Primary Outcome Measures

Name	Time	Method
Changes in Health-related quality of life score	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

Trial Locations

Locations (1)

Mahavachiralongkorn cancer hospital; 🇹🇭 Pathumthani, Thailand