Menu
Recruiting NCT06287294

An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer

Observational Taste, Altered Xerostomia Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Taste, Altered, Xerostomia, Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer.

Detailed description

Patients with advanced cancer often develop taste disturbances. A recent literature review reported a median prevalence of 55%, with prevalence ranging from 27-93%. Studies have shown taste disturbance is usually a persistent symptom, is often 'moderate-to-severe' in intensity, and is often associated with significant distress. Taste disturbance may have a major impact on the experience and pleasure associated with eating and drinking. Taste disturbance may have a major impact on nutritional intake. It may be associated with low mood / depression, social isolation, and an impaired quality of life.

There is limited data available on the aetiology of taste disturbances in patients with advanced cancer, although one group of researchers reported an association between the severity of xerostomia (subjective sensation of dry mouth) and the severity of taste disturbance. Several studies have identified xerostomia and taste disturbance in symptom clusters.

Xerostomia (dry mouth) is defined as the subjective complaint of dry mouth. The prevalence of xerostomia in patients with advanced cancer has been reported to be \>80%. It is the most common oral symptom in patients with advanced cancer. Xerostomia is often a distressing symptom, and is associated with a number of complications including oral discomfort, lip discomfort, cracking of lips, taste disturbances, difficulty chewing, difficulty swallowing, decreased intake of nutrition, oesophagitis, difficulty speaking, poor oral hygiene, halitosis, dental caries, salivary gland infections, oral candidiasis, pneumonia, dental demineralisation (causing dental sensitivity), denture fitting problems, oesophagitis, sleep disturbance, embarrassment, anxiety, depression, and social isolation.

The aforementioned literature review identified the need for observational studies to determine the prevalence, clinical features, "risk factors" and aetiologies for taste disturbance- this data would facilitate targeted screening for the problem. Studies have shown that taste disturbances and xerostomia often co-exist. To the researcher's knowledge, there no evidence on the effect of xerostomia or its treatment on taste problems. This study will explore the relationship between xerostomia and taste problems in patients with advanced cancer.

Primary outcome measures

  • To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire) [Time frame: December 2025]
  • To identify an association of any other oral symptoms present in patients with taste problems and dry mouth who have advanced cancer using the Oral Symptom Assessment Scale (questionnaire) [Time frame: December 2025]
  • To characterise the taste disturbances i.e. to identify reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care (questionnaire) and Waterless Empirical Taste Test (objective taste test) [Time frame: December 2025]
  • To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire). [Time frame: December 2025]
  • To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire). [Time frame: December 2025]

Eligibility criteria

Inclusion criteria

  • 18 years of age
  • Diagnosis of locally advanced or metastatic cancer
  • Referred to palliative care/oncology services
  • Dry mouth rated 'moderate' or worse over previous 2-week period
  • Taste problems rated 'moderate' or worse over previous 2-week period
  • Good understanding of English

Exclusion criteria

  • Cognitive impairment (unable to provide consent / complete questionnaire)
  • Dry mouth precedes cancer diagnosis.
  • Taste problems precedes cancer diagnosis.
  • Head and neck surgery
  • Head and neck radiotherapy
  • Salivary gland disorders (e.g., Sjogren's Syndrome)
  • In the 'Deteriorating' or 'Terminal' Phase of illness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Ireland · 1 center
  • Our Lady's Hospice and Care Services — Dublin

Publications

  • Hannon M, Shaw A, Connolly M, Davies A. Taste disturbance in patients with advanced cancer: a scoping review of clinical features and complications. Support Care Cancer. 2023 Sep 6;31(10):562. doi: 10.1007/s00520-023-08012-x. PMID 37672147
  • Davies A, Buchanan A, Todd J, Gregory A, Batsari KM. Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale. Support Care Cancer. 2021 Aug;29(8):4357-4364. doi: 10.1007/s00520-020-05903-1. Epub 2021 Jan 8. PMID 33416995
  • McGettigan N, Dhuibhir PU, Barrett M, Sui J, Balding L, Higgins S, O'Leary N, Kennedy A, Walsh D. Subjective and Objective Assessment of Taste and Smell Sensation in Advanced Cancer. Am J Hosp Palliat Care. 2019 Aug;36(8):688-696. doi: 10.1177/1049909119832836. Epub 2019 Mar 3. PMID 30827119
  • Twycross RG, Lack SA (1986) Control of alimentary symptoms in far advanced cancer. Churchill Livingstone, Edinburgh
  • Kirkova J, Walsh D, Rybicki L, Davis MP, Aktas A, Tao Jin, Homsi J. Symptom severity and distress in advanced cancer. Palliat Med. 2010 Apr;24(3):330-9. doi: 10.1177/0269216309356380. Epub 2009 Dec 16. PMID 20015920
  • Webber K, Davies AN, Leach C, Waghorn M. Symptom prevalence and severity in palliative cancer medicine. BMJ Support Palliat Care. 2023 Dec 7;13(e2):e270-e272. doi: 10.1136/bmjspcare-2020-002357. PMID 34130997
  • Hutton JL, Baracos VE, Wismer WV. Chemosensory dysfunction is a primary factor in the evolution of declining nutritional status and quality of life in patients with advanced cancer. J Pain Symptom Manage. 2007 Feb;33(2):156-65. doi: 10.1016/j.jpainsymman.2006.07.017. PMID 17280921
  • Rydholm M, Strang P. Physical and psychosocial impact of xerostomia in palliative cancer care: a qualitative interview study. Int J Palliat Nurs. 2002 Jul;8(7):318-23. doi: 10.12968/ijpn.2002.8.7.10671. PMID 12165715

Identifiers

NCT: NCT06287294 · RS23-042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗