Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University
About this trial
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically confirmed solid malignancy
scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2
Disqualifiers
pregnancy
pelvic or abdominal radiation within 4 weeks
uncontrolled brain metastasis
other moderate or high emetic risk chemotherapy on day 2-5
Trial design
Design model
Single group
Treatments tested in this trial
dexamethasone sparing
Drugomit dexamethasone on day 2-4
Treatment groups
95 Participants
are divided into 1 treatment groupGroup A: study armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
complete response rate
no vomiting and no rescue therapy
Time frame
5 days after receiving chemotherapySecondary outcomes
1
no -nausea rate
no nausea symptom
Time frame
5 days after receiving chemotherapy2
degree of nausea vomiting
grading of nausea vomiting
Time frame
5 days after receiving chemotherapy3
adverse effects
adverse effects
Time frame
5 days after receiving chemotherapy4
rescue therapy
additional treatment for nausea or vomiting
Time frame
5 days after chemotherapySponsors and contacts
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Source ClinicalTrials.gov