Trehalose versus carboxymethylcellulose oral spray for relieving radiation-induced xerostomia in head and neck cancer patients: a randomized controlled trial

The aim of this study was to investigate the effect of trehalose oral spray to relieve radiation-induced xerostomia on a randomized controlled trial (RCT). Prior to RCT, the effect of trehalose (5-20%) on the epithelial growth of fetal mouse salivary gland (SG) explants was evaluated to confirm if 1...

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Published in:	BMC oral health Vol. 23; no. 1; p. 288
Main Authors:	Piboonratanakit, Pornpan, Ferreira, Joao N, Pravinvongvuthi, Kulpriya, Maison, Khwanchanok, Urkasemsin, Ganokon, Boonroung, Thirayu, Prayongrat, Anussara, Lertbutsayanukul, Chawalit, Sucharitakul, Jeerus, Vacharaksa, Anjalee
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 13-05-2023 BioMed Central BMC
Subjects:	Carboxymethylcellulose Carboxymethylcellulose Sodium - therapeutic use Care and treatment Clinical trials Complications and side effects Data collection Dental caries Exocrine glands Explants Fetuses Head & neck cancer Head and neck cancer Head and Neck Neoplasms - radiotherapy Health aspects Humans Hyposalivation Management Mitosis Oral Sprays Pain Patient compliance Patient outcomes pH effects Prevention Quality of life Questionnaires Radiation therapy Radiotherapy Risk factors Saliva Salivary gland Software Trehalose Trehalose - pharmacology Trehalose - therapeutic use Xerostomia Xerostomia - drug therapy Xerostomia - etiology Thailand United States > US Hyposalivation Head and neck cancer Salivary gland Trehalose Radiotherapy Xerostomia
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Summary:	The aim of this study was to investigate the effect of trehalose oral spray to relieve radiation-induced xerostomia on a randomized controlled trial (RCT). Prior to RCT, the effect of trehalose (5-20%) on the epithelial growth of fetal mouse salivary gland (SG) explants was evaluated to confirm if 10% trehalose exerted the best epithelial outcomes. Participants who completed radiotherapy for head and neck cancer (HNC) treatment were enrolled in a double-blind RCT, according to inclusion and exclusion criteria as per the CONSORT statement. The experimental group (n = 35) received 10% trehalose spray, while the control group (n = 35) received carboxymethylcellulose (CMC) spray to apply intra-orally 4 times/day for 14 days. Salivary pH and unstimulated salivary flow rate were recorded pre- and post-interventions. The Xerostomia-related Quality of Life scale (XeQoLs) was filled, and scores assessed post-interventions. In the SG explant model, pro-acinar epithelial growth and mitosis was supported by 10% topical trehalose. As for RCT outcomes, salivary pH and unstimulated salivary flow rate were significantly improved after use of 10% trehalose spray when compared to CMC (p < 0.05). Participants reported an improvement of XeQoLs dimension scores after using trehalose or CMC oral sprays in terms of physical, pain/discomfort, and psychological dimensions (p < 0.05), but not social (p > 0.05). When comparing between CMC and trehalose sprays, XeQoLs total scores were not statistically different (p > 0.05). The 10% trehalose spray improved salivary pH, unstimulated salivary flow rate, and the quality-of-life dimensions linked with physical, pain/discomfort, and psychological signs. The clinical efficacy of 10% trehalose spray was equivalent with CMC-based saliva substitutes for relieving radiation-induced xerostomia; therefore, trehalose may be suggested in alternative to CMC-based oral spray.(Thai Clinical Trials Registry; https://www.thaiclinicaltrials.org/ TCTR20190817004).
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	1472-6831 1472-6831
DOI:	10.1186/s12903-023-02966-4