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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Head and Neck Cancer Dysphagia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutri-jelly along with radiotherapy

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

Group Type EXPERIMENTAL

Nutri-jelly

Intervention Type 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

Radiotherapy only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No