Clinical trial NCT03035825: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head Neck
Radiation-Induced Xerostomia
Dry Mouth
Lead sponsor: Dental Innovation Foundation Under Royal Patronage
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: Srinakharinwirot University
name: Ministry of Health, Thailand
First posted: 2017-01-30
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in subjective dry mouth score compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
Secondary outcomes:
measure: Changes in objective dry mouth score compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in salivary pH compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in salivary buffering capacity compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in Candidal counts of saliva compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in energy intake compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in subjective swallow ability compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in appetite compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in tolerance to spicy food
timeFrame: Baseline, 1 and 2 months after intervention
measure: Changes in umami taste recognition threshold compared to baseline
timeFrame: Baseline, 1 and 2 months after intervention
Other outcomes:
Locations:
city: Chonburi
country: Thailand
facility: Chonburi Cancer Hospital
Study officials:
affiliation: Srinakarinwirot University
name: Aroonwan Lam-ubol, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.