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

NCT06495008 | Completed

• 1 other identifier: 11303
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Salivary flow rate 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

  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

  during single hospital visit more than 2 years after anticancer immunotherapy treatment

Study Arms (2)

Patients

Patients with cancer having finished immunotherapy \>2 yrs ago

Other: 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

Interventions

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

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

Patients; caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.
• \. Age \>18 years at time of immune checkpoint inhibitor treatment
• \. Understand or abide to the study procedures
• \. Have given informed consent
• A caregiver must meet all of the following criteria:
• \. Age \>18 years
• \. Understand or abide to the study

You may not qualify if:

• \. As previous or subsequent therapies, only surgery and palliative radiotherapy is allowed (excluding radiotherapy in the head-neck and brain region)
• \. 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)
• \. History of ear-nose-throat disease or auto-immune disorder affecting taste, smell, mouth mucosa, or saliva production (for patients: before start ICI)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Urogenital Neoplasms

Interventions

Taste

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• J. J. de Haan, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: July 10, 2024
• Study Start: October 26, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

NL (1)