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

NCT06287294 | Recruiting

• 1 other identifier: RS23-042
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Taste, Altered; Xerostomia; Neoplasms

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Our Lady's Hospice and Care Services: lead

Study Sites (1)

Our Lady's Hospice and Care Services

Dublin, D6WRY72, Ireland

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Twycross RG, Lack SA (1986) Control of alimentary symptoms in far advanced cancer. Churchill Livingstone, Edinburgh

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 11576798 BACKGROUND

• 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.

  PMID: 20226623 BACKGROUND

• 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.

  PMID: 16482450 BACKGROUND

• 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.

  PMID: 20887509 BACKGROUND

MeSH Terms

Conditions

Dysgeusia; Xerostomia; Neoplasms

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrew Davies, FRCP

  Our Lady's Hospice and Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Davies, FRCP

CONTACT

0035314986235; andavies@tcd.ie

Marie Hannon, BSc

CONTACT

+35314912558; marie.hannon@ucdconnect.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: March 1, 2024
• Study Start: August 30, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)