An observational study in Taste, Altered, Xerostomia and Neoplasms, sponsored by Our Lady's Hospice and Care Services. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Our Lady's Hospice and Care Services · Observational
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.
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.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's planned enrollment of 120 is above the median of 104 across 22 observational studies indexed under Dysgeusia.
Browse Dysgeusia studies →Our Lady's Hospice and Care Services is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: December 2025
Plan to share: No — There is not a plan to make IPD available.
Started Aug 2023 (actual). Primary completion is estimated for Dec 2025, 28 months after the start.
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