The primary objective is to determine the incidence and severity of sicca complaints after ICI administration. The secondary objectives are: 1) to measure changes in objective measures of oral and ocular dryness after ICI administration; 2) to…
ID
Source
Brief title
Condition
- Other condition
- Ocular sensory symptoms NEC
Synonym
Health condition
speekselproductie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Although sicca syndrome is a well-known immune related adverse event (irAE) in
patients treated with immune checkpoint inhibitors (ICIs), its incidence and
spectrum of severity is largely unknown. Based on daily clinical experience, it
is expected that milder sicca symptoms are underreported since patients might
not always report these spontaneously.
Study objective
The primary objective is to determine the incidence and severity of sicca
complaints after ICI administration. The secondary objectives are: 1) to
measure changes in objective measures of oral and ocular dryness after ICI
administration; 2) to investigate whether interferon (IFN) signatures are
predictive of sicca syndrome. An exploring endpoint is to evaluate the efficacy
of early administration of low dose steroids when patients have sicca.
Study design
This is a single institution, prospective study in Erasmus Medical Center to
investigate sicca syndrome after treatment with ICI.
Study burden and risks
The ICIs are administered according to standard of care. There are no
additional risks due to participation in this trial. We expect that there will
be more attention for sicca symptoms which may result in earlier detection.
Then, patients may benefit from (early) advice and treatment for (severe) sicca
symptoms according to standard care.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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 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
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 | NL86156.078.24 |