To determine the prevalence of taste and smell dysfunction in patients more than two years after start of ICI therapy - compared with a control group of caregivers. Secondary objective: to assess the association between taste and smell dysfunction,…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Taste and smell dysfunction, measured using taste strips and Sniffin* Sticks.
Secondary outcome
Salivary flow rate, salivary pH. proteins and electrolytes, xerostomia, and
perceived taste and smell dysfunction and impact of taste and smell
dysfunction.
Background summary
Immune checkpoint inhibitors (ICIs) are widely used as treatment for multiple
cancer types and the number of patients with long-term 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.
Study objective
To determine the prevalence of taste and smell dysfunction in patients more
than two years after start of 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 burden and risks
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.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81573.042.22 |