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

February 22, 2024 updated by: Prof Andrew Davies, Our Lady's Hospice and Care Services
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrew Davies, FRCP
  • Phone Number: 0035314986235
  • Email: andavies@tcd.ie

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland, D6WRY72
        • Recruiting
        • Our Lady's Hospice and Care Services
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 2024
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 2024
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 2024
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 2024
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 2024
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 2024
To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire).
Time Frame: December 2024
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 2024
To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire).
Time Frame: December 2024
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 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady's Hospice and Care Services

Investigators

  • Principal Investigator: Andrew Davies, FRCP, Our Lady's Hospice and Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS23-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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