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Taste and smell dysfunction in patients more than two years after start of immune checkpoint inhibitor therapy

Taste and smell dysfunction in patients more than two years after start of immune checkpoint inhibitor therapy - Taste-SPICIER

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53895
Enrollment
Unknown
Registered
2023-09-13
Start date
2023-10-26
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer malignancy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient 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 procedures 3. Have given informed consent

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Taste and smell dysfunction, measured using taste strips and Sniffin* Sticks.

Secondary

MeasureTime frame
Salivary flow rate, salivary pH. proteins and electrolytes, xerostomia, and perceived taste and smell dysfunction and impact of taste and smell dysfunction.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)