Status:
COMPLETED
Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
Lead Sponsor:
University Medical Center Groningen
Conditions:
Melanoma
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
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. ...
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 11 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06495008
Start Date
October 26 2023
End Date
February 11 2025
Last Update
March 5 2025
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ