Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

Dental Innovation Foundation Under Royal Patronage

Status: Completed

Conditions: Radiation-Induced Xerostomia; Cancer of Head Neck; Dry Mouth

Treatments: Other: Artificial saliva; Dietary Supplement: Oral moisturizing jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT03035825

DIF-05

Details and patient eligibility

About

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

Full description

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.

Enrollment: 73 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Has recurrence of cancer
2. Has mucositis more than grade 1
3. Has oral infection such as candidiasis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Oral Moisturizing Jelly

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral moisturizing jelly

Artificial saliva

Active Comparator group

Description:

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

Treatment:

Other: Artificial saliva