Sesame oil wafers for alleviation of dry mouth.

Phase 2

Recruiting

• Conditions: Post-treatment xerostomia in head and neck cancer patients.; Sesame oil, Saliva Substitute, Head & Neck cancer, Oral mucositis, Dry mouth, and Xerostomia

• Registration Number: TCTR20240326002
• Lead Sponsor: Research unit, Faculty of Dentistry, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Study Completion: 2024-06-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1.Patients with stable head and neck post-cancer treatment.
2.Adults aged 20 years or older.
3.Patients with common comorbidities that cancer patients frequently experience, such as hypertension or diabetes and not the participants with very serious illness.
4.Participants must be consenting adults.

Exclusion Criteria

1.Participant with no or mild dry mouth (subjective dryness score 7).
2.Participant who is allergic to sesame oil, xanthan gum, (salad dressings, bakery products, ice creams) or sodium caseinate (protein powder, coffee creamer, cheese, ice cream).
3.Participant who is taking other treatment for dry mouth.
4.Participant who cannot tolerate a dental examination.
5.Dementia patients
6.Not a bedridden patient and/or No tracheostomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective dry mouth Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. Shortening Xerostomia Inventory,Objective dry mouth Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. The Challacombe scale

Secondary Outcome Measures

Name	Time	Method
Oral mucositis Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. World Health Organization (WHO) oral mucositis scale/common toxicity scale,Dysphagia - Subjective swallowing problem Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. Eating Assessment Tool EAT-10