Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy 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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-01-30

Brief Summary

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This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

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Detailed Description

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Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Conditions

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Cancer of Head Neck Radiation-Induced Xerostomia Dry Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Oral Moisturizing Jelly

Daily intake of oral moisturizing jelly 5 times/day for two months

Group Type EXPERIMENTAL

Oral moisturizing jelly

Intervention Type DIETARY_SUPPLEMENT

Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth

Artificial saliva

Daily use of non-edible oral lubricating gel 5 times/day for two months

Group Type ACTIVE_COMPARATOR

Artificial saliva

Intervention Type OTHER

A non-edible oral lubricating gel for dry mouth patients

Interventions

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Oral moisturizing jelly

Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth

Intervention Type DIETARY_SUPPLEMENT

Artificial saliva

A non-edible oral lubricating gel for dry mouth patients

Intervention Type OTHER

Other Intervention Names

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Dry mouth gel

Eligibility Criteria

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Inclusion Criteria

1. Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
2. If undergoing chemotherapy, have to finish for at least 2 weeks.
3. Have subjective dry mouth scores at least 3
4. Can perform oral intake without aspiration
5. Can communicate well