MelanomaTasteSPICIERNCT06495008
Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
An observational study of Melanoma and Non-small Cell Lung Cancer (NSCLC), run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background of the study: Immune checkpoint inhibitors (ICIs) are widely used as treatment for multiple cancer types and the number of patients with longterm disease control after ICIs is increasing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer (NSCLC), Urogenital Cancers
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Oct 2023to 11 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients (aged >18 years) with melanoma, non-small cell lung cancer (NSCLC) or urogenital cancers who have finshed treatment with an ICI (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) > 2 years ago, and their caregivers.
Who may be able to join
- 1. Patients with melanoma, NSCLC or urogenital cancers > 2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.
- 2. Age >18 years at time of immune checkpoint inhibitor treatment
- 3. Understand or abide to the study procedures
- 4. Have given informed consent
- A caregiver must meet all of the following criteria:
- 1. Age >18 years
- 2. Understand or abide to the study
Who cannot join
- 1. As previous or subsequent therapies, only surgery and palliative radiotherapy is allowed (excluding radiotherapy in the head-neck and brain region)
- 2. Previous treatment in the past ten years for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast) (for patients: other than current malignancy)
- 3. History of ear-nose-throat disease or auto-immune disorder affecting taste, smell, mouth mucosa, or saliva production (for patients: before start ICI)
Trial locations and contacts
1 site in 1 country.
About this study
Background of the study:
Immune checkpoint inhibitors (ICIs) are widely used as treatment for multiple cancer types and the number of patients with longterm disease control after ICIs is increasing. However, the use of ICIs is associated with adverse events (AEs) which can have a negative impact on quality of life (QoL). These AEs include oral manifestations, like alterations in taste and smell, xerostomia, and oral mucosal disorders, and could lead to unwanted weight loss. However, the characteristics of taste and smell dysfunction and xerostomia after treatment with ICIs are unknown. More insight in this phenomenon should be gained to make health care professionals aware of this problem to help patients cope with these AEs.
Read more
Objective of the study:
To determine the prevalence of taste and smell dysfunction in patients more than two years after ICI therapy - compared with a control group of caregivers.
Secondary objective: to assess the association between taste and smell dysfunction, and saliva secretion rate, saliva composition (pH, electrolyte and protein composition) and subjective feeling of a dry mouth (xerostomia) in patients more than two years after start of ICI therapy - compared with a control group of caregivers.
Study design:
Observational cross-sectional study.
Study population:
Patients (aged >18 years) with melanoma, non-small cell lung cancer (NSCLC) or urogenital cancers who have finished treatment with an ICI (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) >2 years ago, and their caregivers.
Primary study parameters/outcome of the study:
Taste and smell dysfunction, measured using taste strips and Sniffin' Sticks.
Secondary study parameters/outcome of the study:
Salivary flow rate, salivary pH, proteins and electrolytes, xerostomia, and perceived taste and smell dysfunction and impact of taste and smell dysfunction.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Participation in the study will include one study visit of approximately 1,5 hours. If possible, the study visit will be combined with a regular follow-up visit. In this study, no invasive procedures will be performed.
Read the detailed description
In this cross-sectional study, patients with melanoma, NSCLC or urogenital cancer ≥ 2 years following ICI therapy and their caregivers will be included. The investigators will include patients who have previously participated in the study "Quality of life, cognitive function, and physical fitness of patients surviving more than 2 years after immune checkpoint inhibitor therapy" and additional patients who are under control at the departments of Medical Oncology and Pulmonary Disease and did not participate in this previous study. A patient cohort of patients and caregivers has already been built and patients who have given permission to be approached for future research again will be invited for our study.
Patients can be approached in two ways: 1) Patients will be asked during an outpatient clinic appointment by their clinical doctor if they can be approached afterwards by the investigator. When permission is given, the investigator will explain the study design and give the patient and the caregiver both a letter. These letters explains the study design and includes an informed consent form, 2) Patients who do not have an outpatient clinic appointment in the near future will be sent the letter with the study design and the informed consent form. In this letter, each participant will be asked to invite their caregiver to participate in this study. For this, a separate letter directed at the caregiver will be sent to the participant. Patients and caregivers are asked to contact the investigator team if they are willing to participate. If the patient consents, a single appointment will be made during a regular follow-up visit to the outpatient clinic. If the caregiver consents too, an appointment will be made with both participants at the same time, if possible. Patients can participate alone if the caregiver is not willing to participate, and vice versa.
During this visit, if patients and caregivers have no questions regarding the study or the study information that was sent, they are first asked to sign the informed consent. Next, saliva will be collected, and taste, smell and dry mouth will be subjectively and objectively be measured. Afterwards, characteristics will be taken from the patients' electronic file, including age, gender, medical history and medication use. As the caregivers do not have a medical file, they are asked for these characteristics.
- Being tested
- no intervention, only questionnaires, saliva collection and taste/smell tests
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, only questionnaires, saliva collection and taste/smell testsOther
no intervention, only questionnaires, saliva collection and taste/smell tests
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with cancer having finished immunotherapy >2 yrs ago Receives: Other: no intervention, only questionnaires, saliva collection and taste/smell tests | |
| caregivers | Caregivers of patients with cancer Receives: Other: no intervention, only questionnaires, saliva collection and taste/smell tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste function, score of test with taste strips
Taste function measured using taste strips in patients compared to caregivers, resulting in a score of 0-16 points with 16 being the best outcome.
Measured: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Secondary outcomes (4)
Salivary flow rate in mL/min
Salivary flow rate, stimulated and unstimulated production of saliva in cup in 5 minutes, in mL/min
Measured: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Perceived taste and smell dysfunction, as determined using a standardized questionnaire
Perceived taste and smell dysfunction, as determined using a standardized questionnaire
Measured: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Perceived xerostomia, using standardized questionnaire
Perceived xerostomia, using standardized questionnaire
Measured: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Smell function
Smell function measured using Sniffin' Sticks in patients compared to caregivers, resulting in a score of 0-16.
Measured: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start26 Oct 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. J. de Haan, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495008
- Sponsor's protocol ID
- 11303
- Acronym
- TasteSPICIER
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Elst JM, Buffinga CM, Brand HS, Hijmering-Kappelle LBM, Jager-Wittenaar H, Reyners AKL, Nuver J, de Haan JJ. Prevalence and characteristics of persistent taste and smell dysfunction after immune checkpoint inhibitor therapy for cancer. Support Care Cancer. 2026 May 21;34(6):564. doi: 10.1007/s00520-026-10761-4.
PubMed 42165900
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT06495008
- Acronym / sponsor ID
- TasteSPICIER / 11303
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 10 Jul 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.
Background of the study:
Immune checkpoint inhibitors (ICIs) are widely used as treatment for multiple cancer types and the number of patients with longterm disease control after ICIs is increasing. However, the use of ICIs is associated with adverse events (AEs) which can have a negative impact on quality of life (QoL). These AEs include oral manifestations, like alterations in taste and smell, xerostomia, and oral mucosal disorders, and could lead to unwanted weight loss. However, the characteristics of taste and smell dysfunction and xerostomia after treatment with ICIs are unknown. More insight in this phenomenon should be gained to make health care professionals aware of this problem to help patients cope with these AEs.
Objective of the study:
To determine the prevalence of taste and smell dysfunction in patients more than two years after ICI therapy - compared with a control group of caregivers.
Secondary objective: to assess the association between taste and smell dysfunction, and saliva secretion rate, saliva composition (pH, electrolyte and protein composition) and subjective feeling of a dry mouth (xerostomia) in patients more than two years after start of ICI therapy - compared with a control group of caregivers.
Study design:
Observational cross-sectional study.
Study population:
Patients (aged >18 years) with melanoma, non-small cell lung cancer (NSCLC) or urogenital cancers who have finished treatment with an ICI (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) >2 years ago, and their caregivers.
Primary study parameters/outcome of the study:
Taste and smell dysfunction, measured using taste strips and Sniffin' Sticks.
Secondary study parameters/outcome of the study:
Salivary flow rate, salivary pH, proteins and electrolytes, xerostomia, and perceived taste and smell dysfunction and impact of taste and smell dysfunction.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Participation in the study will include one study visit of approximately 1,5 hours. If possible, the study visit will be combined with a regular follow-up visit. In this study, no invasive procedures will be performed.
Detailed description
In this cross-sectional study, patients with melanoma, NSCLC or urogenital cancer ≥ 2 years following ICI therapy and their caregivers will be included. The investigators will include patients who have previously participated in the study "Quality of life, cognitive function, and physical fitness of patients surviving more than 2 years after immune checkpoint inhibitor therapy" and additional patients who are under control at the departments of Medical Oncology and Pulmonary Disease and did not participate in this previous study. A patient cohort of patients and caregivers has already been built and patients who have given permission to be approached for future research again will be invited for our study.
Patients can be approached in two ways: 1) Patients will be asked during an outpatient clinic appointment by their clinical doctor if they can be approached afterwards by the investigator. When permission is given, the investigator will explain the study design and give the patient and the caregiver both a letter. These letters explains the study design and includes an informed consent form, 2) Patients who do not have an outpatient clinic appointment in the near future will be sent the letter with the study design and the informed consent form. In this letter, each participant will be asked to invite their caregiver to participate in this study. For this, a separate letter directed at the caregiver will be sent to the participant. Patients and caregivers are asked to contact the investigator team if they are willing to participate. If the patient consents, a single appointment will be made during a regular follow-up visit to the outpatient clinic. If the caregiver consents too, an appointment will be made with both participants at the same time, if possible. Patients can participate alone if the caregiver is not willing to participate, and vice versa.
During this visit, if patients and caregivers have no questions regarding the study or the study information that was sent, they are first asked to sign the informed consent. Next, saliva will be collected, and taste, smell and dry mouth will be subjectively and objectively be measured. Afterwards, characteristics will be taken from the patients' electronic file, including age, gender, medical history and medication use. As the caregivers do not have a medical file, they are asked for these characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: no intervention, only questionnaires, saliva collection and taste/smell testsPatients with cancer having finished immunotherapy >2 yrs ago |
| caregivers | – | Other: no intervention, only questionnaires, saliva collection and taste/smell testsCaregivers of patients with cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (aged >18 years) with melanoma, non-small cell lung cancer (NSCLC) or urogenital cancers who have finshed treatment with an ICI (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) > 2 years ago, and their caregivers.
Key inclusion criteria (7 listed)
- 1. Patients with melanoma, NSCLC or urogenital cancers > 2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.
- 2. Age >18 years at time of immune checkpoint inhibitor treatment
- 3. Understand or abide to the study procedures
- 4. Have given informed consent
- 1. Age >18 years
Key exclusion criteria (3 listed)
- 1. As previous or subsequent therapies, only surgery and palliative radiotherapy is allowed (excluding radiotherapy in the head-neck and brain region)
- 2. Previous treatment in the past ten years for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast) (for patients: other than current malignancy)
- 3. History of ear-nose-throat disease or auto-immune disorder affecting taste, smell, mouth mucosa, or saliva production (for patients: before start ICI)
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 |
|---|---|---|
| no intervention, only questionnaires, saliva collection and taste/smell testsno intervention, only questionnaires, saliva collection and taste/smell tests | Other | Patients, caregivers |
Primary outcome
Taste function, score of test with taste strips
Time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Taste function measured using taste strips in patients compared to caregivers, resulting in a score of 0-16 points with 16 being the best outcome.
4 secondary outcomes
Salivary flow rate in mL/min
Time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Perceived taste and smell dysfunction, as determined using a standardized questionnaire
Time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Perceived xerostomia, using standardized questionnaire
Time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Smell function
Time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 42165900van Elst JM, Buffinga CM, Brand HS, Hijmering-Kappelle LBM, Jager-Wittenaar H, Reyners AKL, Nuver J, de Haan JJ. Prevalence and characteristics of persistent taste and smell dysfunction after immune checkpoint inhibitor therapy for cancer. Support Care Cancer. 2026 May 21;34(6):564. doi: 10.1007/s00520-026-10761-4.
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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.
J. J. de Haan, MD, PhD principal investigator
University Medical Center Groningen
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 Melanoma and Non-small Cell Lung Cancer (NSCLC), run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 5 Mar 2025. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste function, score of test with taste strips (time frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment). 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 NCT06495008, which also lists 1 linked publication.
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 5 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.