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NCT Number: NCT06287294

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

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.

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Key information

Conditions

Taste, Altered Dysgeusia Mouth Diseases Neoplasms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Sensation Disorders Signs and Symptoms Stomatognathic Diseases Taste Disorders Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 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.

  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)

    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) 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.

  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)

    Time frame: December 2025

    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.

  4. 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 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.

  5. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Davies, FRCP

CONTACT

[email protected]

0035314986235

Marie Hannon, BSc

CONTACT

[email protected]

+35314912558

Sponsors and collaborators

Lead sponsor

Our Lady's Hospice and Care Services

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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