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

Dental Innovation Foundation Under Royal Patronage

Status: Completed

Conditions: Dysphagia; Head and Neck Cancer

Treatments: Dietary Supplement: Nutri-jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT01871155

DIF-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 64 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Nutri-jelly along with radiotherapy

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutri-jelly

Radiotherapy only

No Intervention group

Description:

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