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

NCT06495008 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2025-03-05

No results posted yet for this study

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. 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.

Conditions

  • Melanoma
  • Non-small Cell Lung Cancer (NSCLC)
  • Urogenital Cancers

Interventions

OTHER

no intervention, only questionnaires, saliva collection and taste/smell tests

no intervention, only questionnaires, saliva collection and taste/smell tests

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • J. J. de Haan, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2025-02-11
Completion
2025-02-11

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06495008 on ClinicalTrials.gov