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

Primary Purpose

Cancer of Head Neck, Radiation-Induced Xerostomia, Dry Mouth

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Oral moisturizing jelly
Artificial saliva
Sponsored by
Dental Innovation Foundation Under Royal Patronage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Head Neck

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chonburi Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Moisturizing Jelly

Artificial saliva

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in subjective dry mouth score compared to baseline
Evaluation of subjective dry mouth score by questionaire

Secondary Outcome Measures

Changes in objective dry mouth score compared to baseline
Evaluation of objective dry mouth score by oral examination
Changes in salivary pH compared to baseline
Evaluation of salivary pH using pH indicator paper
Changes in salivary buffering capacity compared to baseline
Evaluation of salivary buffering capacity using a commercial saliva check buffer kit
Changes in Candidal counts of saliva compared to baseline
Evaluation of number of fungal colonies of Candida spp. in saliva by culture
Changes in energy intake compared to baseline
Evaluation of energy intake per day using dietary record and analysis
Changes in subjective swallow ability compared to baseline
Evaluation of subjective swallow ability using EAT-10 questionaire
Changes in appetite compared to baseline
Evaluation of appetite using questionnaire
Changes in tolerance to spicy food
Evaluation of tolerance to spicy food using questionnaire
Changes in umami taste recognition threshold compared to baseline
Evaluation of umami taste recognition threshold using filter paper disc method

Full Information

First Posted
January 25, 2017
Last Updated
February 7, 2019
Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT03035825
Brief Title
Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients
Official Title
A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head Neck, Radiation-Induced Xerostomia, Dry Mouth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Moisturizing Jelly
Arm Type
Experimental
Arm Description
Daily intake of oral moisturizing jelly 5 times/day for two months
Arm Title
Artificial saliva
Arm Type
Active Comparator
Arm Description
Daily use of non-edible oral lubricating gel 5 times/day for two months
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral moisturizing jelly
Intervention Description
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
Intervention Type
Other
Intervention Name(s)
Artificial saliva
Other Intervention Name(s)
Dry mouth gel
Intervention Description
A non-edible oral lubricating gel for dry mouth patients
Primary Outcome Measure Information:
Title
Changes in subjective dry mouth score compared to baseline
Description
Evaluation of subjective dry mouth score by questionaire
Time Frame
Baseline, 1 and 2 months after intervention
Secondary Outcome Measure Information:
Title
Changes in objective dry mouth score compared to baseline
Description
Evaluation of objective dry mouth score by oral examination
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in salivary pH compared to baseline
Description
Evaluation of salivary pH using pH indicator paper
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in salivary buffering capacity compared to baseline
Description
Evaluation of salivary buffering capacity using a commercial saliva check buffer kit
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in Candidal counts of saliva compared to baseline
Description
Evaluation of number of fungal colonies of Candida spp. in saliva by culture
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in energy intake compared to baseline
Description
Evaluation of energy intake per day using dietary record and analysis
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in subjective swallow ability compared to baseline
Description
Evaluation of subjective swallow ability using EAT-10 questionaire
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in appetite compared to baseline
Description
Evaluation of appetite using questionnaire
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in tolerance to spicy food
Description
Evaluation of tolerance to spicy food using questionnaire
Time Frame
Baseline, 1 and 2 months after intervention
Title
Changes in umami taste recognition threshold compared to baseline
Description
Evaluation of umami taste recognition threshold using filter paper disc method
Time Frame
Baseline, 1 and 2 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month. If undergoing chemotherapy, have to finish for at least 2 weeks. Have subjective dry mouth scores at least 3 Can perform oral intake without aspiration Can communicate well Exclusion Criteria: Has recurrence of cancer Has mucositis more than grade 1 Has oral infection such as candidiasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aroonwan Lam-ubol, DDS, PhD
Organizational Affiliation
Srinakarinwirot University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonburi Cancer Hospital
City
Chonburi
ZIP/Postal Code
20000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32779011
Citation
Lam-Ubol A, Matangkasombut O, Trachootham D, Tarapan S, Sattabanasuk V, Talungchit S, Paemuang W, Phonyiam T, Chokchaitam O, Mungkung OO. Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial. Clin Oral Investig. 2021 Apr;25(4):1815-1827. doi: 10.1007/s00784-020-03484-1. Epub 2020 Aug 10.
Results Reference
derived
PubMed Identifier
31732852
Citation
Nuchit S, Lam-Ubol A, Paemuang W, Talungchit S, Chokchaitam O, Mungkung OO, Pongcharoen T, Trachootham D. Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2817-2828. doi: 10.1007/s00520-019-05132-1. Epub 2019 Nov 15.
Results Reference
derived

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

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