NCT06287294|Unknown
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Sponsor study identifier
observational
120
1 country
1
Study Start
August 30, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2023
Actual (reported)November 20, 2023
Actual (reported)March 1, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire)
To measure the prevalence of taste problems in patients with advanced cancer who have a dry mouth using the validated Oral Symptom Assessment Scale, which is a 20 question questionnaire which asks about the presence of symptoms in the previous week, the frequency of the symptoms, the severity of the symptoms, and the amount of distress/"bothersomeness" caused by the symptoms.
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)
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) which asks about the presence of symptoms in the previous week, the frequency of the symptoms, the severity of the symptoms, and the amount of distress/"bothersomeness" caused by the symptoms.
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)
To characterise the taste disturbances i.e. for reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care, which is a 16 question questionnaire which asks about the presence of taste problems in the previous fortnight, the frequency of the symptoms, the severity of the symptoms, and the amount of distress/"bothersomeness" caused by these symptoms. An objective taste test, the Waterless Empirical Taste Test will also be used. This is comprised of taste strips with monomer cellulose pads impregnated with solutions dried of sucrose, citric acid, sodium chloride, caffeine, monosodium glutamate, or no stimulus. The participant is instructed to move the cellulose pad of each strip around the mouth for 5-10 seconds, and to identify the taste quality or to indicate that no taste can be perceived.
Patients who are currently under the care of oncology or palliative care who have an incurable cancer. Patients will be identified by the clinical teams at the study sites, informed about the study, and (if interested in taking part in the study) referred to the research team. Participants will be screened for inclusion by asking, "1. Over the last 2 weeks have you experienced having a dry mouth? 2. Over the past 2 weeks have you experienced taste problems?" If yes to either question, "How severe was it? (Options- Slight/Moderate/Severe/Very severe)". Patients must score as moderate/severe/very severe.
Our Lady's Hospice and Care Services
Dublin, D6WRY72, Ireland
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.
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.
Andrew Davies, FRCP
Our Lady's Hospice and Care Services
First Submitted
November 20, 2023
First Posted
March 1, 2024
Study Start
August 30, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia
December 2025
To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire).
To identify the impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire) which is a 16 question questionnaire which asks about the presence of taste problems and xerostomia in the previous fortnight, the frequency of the symptoms, the severity of the symptoms, and the amount of distress/"bothersomeness" caused by these symptoms.
December 2025
To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire).
To identify the impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire) which is a 16 question questionnaire which asks about the presence of taste problems and xerostomia in the previous fortnight, the frequency of the symptoms, the severity of the symptoms, and the amount of distress/"bothersomeness" caused by these symptoms.
December 2025
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Davies AN, Broadley K, Beighton D. Xerostomia in patients with advanced cancer. J Pain Symptom Manage. 2001 Oct;22(4):820-5. doi: 10.1016/s0885-3924(01)00318-9.
Tsai JS, Wu CH, Chiu TY, Chen CY. Significance of symptom clustering in palliative care of advanced cancer patients. J Pain Symptom Manage. 2010 Apr;39(4):655-62. doi: 10.1016/j.jpainsymman.2009.09.005. Epub 2010 Mar 11.
Walsh D, Rybicki L. Symptom clustering in advanced cancer. Support Care Cancer. 2006 Aug;14(8):831-6. doi: 10.1007/s00520-005-0899-z. Epub 2006 Feb 16.
Hopcraft MS, Tan C. Xerostomia: an update for clinicians. Aust Dent J. 2010 Sep;55(3):238-44; quiz 353. doi: 10.1111/j.1834-7819.2010.01229.x.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2024
Record last verified: 2024-09
There is not a plan to make IPD available.
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