Altered TasteNCT06588933
TQ-PAL Development and Validation
An observational study of Altered Taste, run by Prof Andrew Davies at 1 site in Ireland.
Trial summary
Taste problems 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. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Altered Taste
- What is being tested?
- completion of a questionnaire
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 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
- 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 past 2 weeks have you experienced taste problems?" If yes to the 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 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) 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.
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospice & Care Services
Dublin, D6WRY72
Andrew Davies, FRCP, 0035314986235, andavies@tcd.ie
Marie Hannon, BSc, 0035314068720, marie.hannon@ucdconnect.ie
About this study
Official title: The Development and Validation of a Novel Tool for the Assessment of Taste Disturbances in Patients With Advanced Cancer: Taste Questionnaire in Palliative Care
Taste problems 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. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. This study will develop and validate a novel assessment tool to assess taste disturbances and their impact on 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.
The aforementioned literature review identified, importantly, that the terminology used in the published literature varied, which may have had an effect on the results obtained, especially prevalence statistics. The review identified the need for "development/validation studies of a taste-specific assessment tool for this group of patients - there is a need for a tool that not only assesses the problem but can also assess the response to treatment for the problem, utilising patient reported outcome measures."
- Conditions
- Altered Taste
- Being tested
- completion of a questionnaire
- Keywords
- neoplasm
- Medical subject headings
- Dysgeusia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of a questionnaireOther
completion of a questionnaire by participant
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer
To develop the Taste Questionnaire in Palliative Care (TQ-PAL) to assess taste disturbances and their impact on patients with palliative care. It's domains include the effect on food intake, social inclusion, and quality of life
Measured: December 2025
To validate the newly developed Taste Questionnaire in Palliative Care (TQ-PAL)
To test the TQ-PAL for face, content, construct, convergent and reliability validation.
Measured: December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Altered TasteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Andrew Davies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Andrew Davies, Our Lady's Hospice and Care Services
- Investigators
- Andrew Davies, FRCP, Principal investigator, Our Lady's Hospice and Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588933
- Sponsor's protocol ID
- Our Lady's Hospice
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37672147McGettigan 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 30827119Hutton 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 17280921Kirkova 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Validation of a Novel Tool for the Assessment of Taste Disturbances in Patients With Advanced Cancer: Taste Questionnaire in Palliative Care
- ClinicalTrials.gov ID
- NCT06588933
- Acronym / sponsor ID
- Our Lady's Hospice
- Conditions
- Altered Taste
- Keywords
- neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prof Andrew DaviesUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taste problems 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. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. This study will develop and validate a novel assessment tool to assess taste disturbances and their impact on patients with advanced cancer.
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.
The aforementioned literature review identified, importantly, that the terminology used in the published literature varied, which may have had an effect on the results obtained, especially prevalence statistics. The review identified the need for "development/validation studies of a taste-specific assessment tool for this group of patients - there is a need for a tool that not only assesses the problem but can also assess the response to treatment for the problem, utilising patient reported outcome measures."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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 past 2 weeks have you experienced taste problems?" If yes to the question, "How severe was it? (Options- Slight/Moderate/Severe/Very severe)". Patients must score as moderate/severe/very severe
Key inclusion criteria (1 listed)
- 18 years of age Diagnosis of locally advanced or metastatic cancer Referred to palliative care/oncology services Taste problems rated 'moderate' or worse over previous 2-week period Good understanding of English
Key exclusion criteria (1 listed)
- Cognitive impairment (unable to provide consent / complete questionnaire) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of a questionnairecompletion of a questionnaire by participant | Other | – |
Primary outcome
To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer
Time frame: December 2025
To develop the Taste Questionnaire in Palliative Care (TQ-PAL) to assess taste disturbances and their impact on patients with palliative care. It's domains include the effect on food intake, social inclusion, and quality of life
To validate the newly developed Taste Questionnaire in Palliative Care (TQ-PAL)
Time frame: December 2025
To test the TQ-PAL for face, content, construct, convergent and reliability validation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 37672147Hannon 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.
- Background: PubMed 30827119McGettigan 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.
- Background: PubMed 17280921Hutton 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.
- Background: PubMed 20015920Kirkova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davies, FRCP principal investigator
Our Lady's Hospice and Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altered Taste, run by Prof Andrew Davies 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 1 inclusion and 1 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 (014986235, andavies@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer (time frame: December 2025). The study lists 2 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 NCT06588933, which also lists 4 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.