speekselproductie dry eyes and/or dry mouth
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Treatment with first-line monotherapy anti-PD(L)1 or combination therapy with anti-PD(L)1 and anti-CTLA4 for the treatment of e.g. melanoma, renal cell, esophagus, and urothelial cell cancer. • ICI can be administered in the metastatic, inoperable or (neo)adjuvant setting in accordance with the current standard of care.
Exclusion criteria
Exclusion criteria: Exclusion criteria are the following: • Combination therapy with chemotherapy, targeted therapy or tyrosine kinase inhibitors • Previous treatment with ICI, including anti-PD(L)1 and anti-CTLA4 • Concurrent treatment with the following medication: anticholinergic medications, alpha receptor antagonist, antipsychotics, and antihistamines • History of systemic autoimmune disease (rheumatoid arthritis, Sjögren*s disease, systemic sclerosis, inflammatory myopathies and sarcoidosis) • History of salivary gland irradiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to examine the incidence and severity of sicca symptoms after ICI administration at 3 and 6 months. Depending on the results of this study, we will consider to perform a future study to evaluate the effect of early administration of low dose steroids to treat symptoms of the sicca syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective(s): The secondary objectives are: 1) to measure changes in objective measures of oral and ocular dryness after ICI administration; 2) to investigate whether IFN signatures are a predictive marker of sicca syndrome. Exploratory objective To evaluate the efficacy of early administration of low dose steroids for patients with reported sicca. | — |
Countries
Netherlands
Outcome results
None listed