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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03035825
Other study ID # DIF-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date January 30, 2019

Study information

Verified date February 2019
Source Dental Innovation Foundation Under Royal Patronage
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Oral moisturizing jelly
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
Other:
Artificial saliva
A non-edible oral lubricating gel for dry mouth patients

Locations

Country Name City State
Thailand Chonburi Cancer Hospital Chonburi

Sponsors (4)

Lead Sponsor Collaborator
Dental Innovation Foundation Under Royal Patronage Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in subjective dry mouth score compared to baseline Evaluation of subjective dry mouth score by questionaire Baseline, 1 and 2 months after intervention
Secondary Changes in objective dry mouth score compared to baseline Evaluation of objective dry mouth score by oral examination Baseline, 1 and 2 months after intervention
Secondary Changes in salivary pH compared to baseline Evaluation of salivary pH using pH indicator paper Baseline, 1 and 2 months after intervention
Secondary Changes in salivary buffering capacity compared to baseline Evaluation of salivary buffering capacity using a commercial saliva check buffer kit Baseline, 1 and 2 months after intervention
Secondary Changes in Candidal counts of saliva compared to baseline Evaluation of number of fungal colonies of Candida spp. in saliva by culture Baseline, 1 and 2 months after intervention
Secondary Changes in energy intake compared to baseline Evaluation of energy intake per day using dietary record and analysis Baseline, 1 and 2 months after intervention
Secondary Changes in subjective swallow ability compared to baseline Evaluation of subjective swallow ability using EAT-10 questionaire Baseline, 1 and 2 months after intervention
Secondary Changes in appetite compared to baseline Evaluation of appetite using questionnaire Baseline, 1 and 2 months after intervention
Secondary Changes in tolerance to spicy food Evaluation of tolerance to spicy food using questionnaire Baseline, 1 and 2 months after intervention
Secondary Changes in umami taste recognition threshold compared to baseline Evaluation of umami taste recognition threshold using filter paper disc method Baseline, 1 and 2 months after intervention
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