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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone replacement | Experimental | 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 â–¶ measure hiccup and nausea/vomiting severity Treatment period * Methylprednisolone 60mg-125mg iv during chemotherapy â–¶ 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention rate of dexamethasone induced hiccup | measure the presence of hiccup and its severity 24 hous after chemotherapy | 24hrs after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention rate of nausea and vomiting | Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively | acute; 24 hours, delayed; 7 days after chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Hun Kang, M.D, Ph.D | Gyeongsang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeongsang University Hospital | Jinju | South Korea |
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| ID | Term |
|---|---|
| D006606 | Hiccup |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |