Dexamethasone, Hiccup
Conditions
Brief summary
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.
Interventions
DRUGMethylprednisolone
Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
Sponsors
Gyeongsang National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age olderthan 21 * A Patient on chemotherapy who was diagnosed malignant tumor * A Patient who is newly developed hiccup in the course of chemotherapy * A patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it * A patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Exclusion criteria
* A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications * A patient with uncontrolled diabetes * A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases * A patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention rate of dexamethasone induced hiccup | 24hrs after chemotherapy | measure the presence of hiccup and its severity 24 hous after chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention rate of nausea and vomiting | acute; 24 hours, delayed; 7 days after chemotherapy | Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively |
Countries
South Korea
Outcome results
None listed