Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495008
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-01-02
Brief Title:
Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Taste and Smell Dysfunction in Patients More Than Two Years After Start of Immune Checkpoint Inhibitor Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TasteSPICIER
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-L1 inhibitor or both 2 years ago and their caregivers
Primary study parametersoutcome of the study
Taste and smell dysfunction measured using taste strips and Sniffin Sticks
Secondary study parametersoutcome 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 15 hours If possible the study visit will be combined with a regular follow-up visit In this study no invasive procedures will be performed
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-L1 inhibitor or both 2 years ago and their caregivers
Primary study parametersoutcome of the study
Taste and smell dysfunction measured using taste strips and Sniffin Sticks
Secondary study parametersoutcome 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 15 hours If possible the study visit will be combined with a regular follow-up visit In this study no invasive procedures will be performed
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 have previously participated in the study Quality of life cognitive function and physical fitness of patients surviving more than 2 years after immune checkpoint inhibitor therapy and additional patients who are under control at the departments of Medical Oncology and Pulmonary Disease and did not participate in this previous study A patient cohort of patients and caregivers has already been built and patients who have given permission to be approached for future research again will be invited for our study
Patients can be approached in two ways 1 Patients will be asked during an outpatient clinic appointment by their clinical doctor if they can be approached afterwards by the investigator When permission is given the investigator will explain the study design and give the patient and the caregiver both a letter These letters explains the study design and includes an informed consent form 2 Patients who do not have an outpatient clinic appointment in the near future will be sent the letter with the study design and the informed consent form In this letter each participant will be asked to invite their caregiver to participate in this study For this a separate letter directed at the caregiver will be sent to the participant Patients and caregivers are asked to contact the investigator team if they are willing to participate If the patient consents a single appointment will be made during a regular follow-up visit to the outpatient clinic If the caregiver consents too an appointment will be made with both participants at the same time if possible Patients can participate alone if the caregiver is not willing to participate and vice versa
During this visit if patients and caregivers have no questions regarding the study or the study information that was sent they are first asked to sign the informed consent Next saliva will be collected and taste smell and dry mouth will be subjectively and objectively be measured Afterwards characteristics will be taken from the patients electronic file including age gender medical history and medication use As the caregivers do not have a medical file they are asked for these characteristics
Patients can be approached in two ways 1 Patients will be asked during an outpatient clinic appointment by their clinical doctor if they can be approached afterwards by the investigator When permission is given the investigator will explain the study design and give the patient and the caregiver both a letter These letters explains the study design and includes an informed consent form 2 Patients who do not have an outpatient clinic appointment in the near future will be sent the letter with the study design and the informed consent form In this letter each participant will be asked to invite their caregiver to participate in this study For this a separate letter directed at the caregiver will be sent to the participant Patients and caregivers are asked to contact the investigator team if they are willing to participate If the patient consents a single appointment will be made during a regular follow-up visit to the outpatient clinic If the caregiver consents too an appointment will be made with both participants at the same time if possible Patients can participate alone if the caregiver is not willing to participate and vice versa
During this visit if patients and caregivers have no questions regarding the study or the study information that was sent they are first asked to sign the informed consent Next saliva will be collected and taste smell and dry mouth will be subjectively and objectively be measured Afterwards characteristics will be taken from the patients electronic file including age gender medical history and medication use As the caregivers do not have a medical file they are asked for these characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None