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Taste, AlteredNCT06287294

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

An observational study of Taste, Altered and Xerostomia, run by Our Lady's Hospice and Care Services at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Taste, Altered, Xerostomia, Neoplasms
How many people
120 participants
Where
1 siteIreland
Study dates
30 Aug 2023to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Andrew Davies, FRCP contact

0035314986235

andavies@tcd.ie

Ireland1 site, 1 recruiting
  • Our Lady's Hospice and Care Services

    Dublin, D6WRY72

    Andrew Davies, FRCP, 0035314986235, andavies@tcd.ie

    Marie Hannon, BSc, 0035314912558, marie.hannon@ucdconnect.ie

    Recruiting

Other trials in Ireland

About this study

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.

Read the 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.

Medical subject headings
Dysgeusia, Xerostomia, Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: December 2025

  2. 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.

    Measured: December 2025

  3. 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.

    Measured: December 2025

  4. 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.

    Measured: December 2025

  5. 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.

    Measured: December 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start30 Aug 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287294
Sponsor's protocol ID
RS23-042
Status last verified
Sep 2024
First submitted
20 Nov 2023
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 12165715
  • 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.

    PubMed 11576798
  • 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.

    PubMed 20226623
  • 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.

    PubMed 16482450
  • 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.

    PubMed 20887509

Questions about this trial

What is this clinical trial studying?

An observational study of Taste, Altered and Xerostomia, run by Our Lady's Hospice and Care Services at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrew Davies, FRCP (0035314986235, andavies@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06287294, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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