An interventional study of Methylprednisolone in Dexamethasone and Hiccup, sponsored by Gyeongsang National University Hospital. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-11-20.
Sponsored by Gyeongsang National University Hospital · Not applicable, Interventional, and Treatment
Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group.
Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. The investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.
Gyeongsang National University Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This study will enroll the patients who were previously experienced dexamethasone-induced hiccup. Patients who experienced dexamethasone-induced hiccup during chemotherapy will enroll to study arm. Run-in period \* Dexamethasone 10mg-20mg q day iv during chemotherapy ▶ measure hiccup and nausea/vomiting severity Treatment period \* Methylprednisolone 60mg-125mg iv during chemotherapy ▶ measure hiccup and nausea/vomiting severity Response will be evaluated by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and NRS to hiccup at 24hrs after start methylprednisolone. Nausea and vomiting will be assessed as CTCAE 4.0
Drug: Methylprednisolone
Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
Prevention rate of dexamethasone induced hiccup
measure the presence of hiccup and its severity 24 hous after chemotherapy
Time frame: 24hrs after chemotherapy
Prevention rate of nausea and vomiting
Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively
Time frame: acute; 24 hours, delayed; 7 days after chemotherapy
This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Hiccup
Gyeongsang National University Hospital