Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
NCT Number: NCT06495008
Acronym: TasteSPICIER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Melanoma|Non-small Cell Lung Cancer (NSCLC)|Urogenital Cancers
Interventions: OTHER: no intervention, only questionnaires, saliva collection and taste/smell tests
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-26
Completion Date: 2024-09-01
Locations: University Medical Center Groningen, Groningen, 9713 GZ, Netherlands

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.

Primary Outcome Measures: 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., during single hospital visit more than 2 years after anticancer immunotherapy treatment
Secondary Outcome Measures: Salivary flow rate in mL/min, 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, 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, Perceived xerostomia, using standardized questionnaire, 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., during single hospital visit more than 2 years after anticancer immunotherapy treatment