NCT03035825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

January 25, 2017

Last Update Submit

February 7, 2019

Conditions

Cancer of Head NeckRadiation-Induced XerostomiaDry Mouth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Changes in objective dry mouth score compared to baseline

    Baseline, 1 and 2 months after intervention

  • Changes in salivary pH compared to baseline

    Baseline, 1 and 2 months after intervention

  • Changes in salivary buffering capacity compared to baseline

    Baseline, 1 and 2 months after intervention

  • Changes in Candidal counts of saliva compared to baseline

    Baseline, 1 and 2 months after intervention

  • Changes in energy intake compared to baseline

    Baseline, 1 and 2 months after intervention

  • +4 more secondary outcomes

Study Arms (2)

Oral Moisturizing Jelly

EXPERIMENTAL

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

Dietary Supplement: Oral moisturizing jelly

Artificial saliva

ACTIVE COMPARATOR

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

Other: Artificial saliva

Interventions

Oral moisturizing jellyDIETARY_SUPPLEMENT

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

Oral Moisturizing Jelly
Artificial salivaOTHER

A non-edible oral lubricating gel for dry mouth patients

Also known as: Dry mouth gel
Artificial saliva

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Has recurrence of cancer
  • Has mucositis more than grade 1
  • Has oral infection such as candidiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonburi Cancer Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 32779011DERIVED

  • 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.

    PMID: 31732852DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsXerostomia

Interventions

Saliva, Artificial

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

MouthwashesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Aroonwan Lam-ubol, DDS, PhD

    Srinakarinwirot University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 30, 2017

Study Start

March 1, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)