Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy (TasteSPICIER)

March 4, 2025 updated by: University Medical Center Groningen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients
Patients with cancer having finished immunotherapy >2 yrs ago
Other: no intervention, only questionnaires, saliva collection and taste/smell tests
no intervention, only questionnaires, saliva collection and taste/smell tests
caregivers
Caregivers of patients with cancer
Other: no intervention, only questionnaires, saliva collection and taste/smell tests
no intervention, only questionnaires, saliva collection and taste/smell tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during single hospital visit more than 2 years after anticancer immunotherapy treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary flow rate in mL/min
Time Frame: during single hospital visit more than 2 years after anticancer immunotherapy treatment
Salivary flow rate, stimulated and unstimulated production of saliva in cup in 5 minutes, in mL/min
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 taste and smell dysfunction, as determined using a standardized questionnaire
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
Perceived xerostomia, using standardized questionnaire
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
Smell function measured using Sniffin' Sticks in patients compared to caregivers, resulting in a score of 0-16.
during single hospital visit more than 2 years after anticancer immunotherapy treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Groningen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. J. de Haan, MD, PhD, University Medical Center Groningen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11303 (DAIDS ES Registry Number)

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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