Methylprednisolone Replacement for Dexamethasone-induced Hiccup
Information source: Gyeongsang National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dexamethasone; Hiccup
Intervention: Methylprednisolone (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Gyeongsang National University Hospital Official(s) and/or principal investigator(s): Jung Hun Kang, M.D, Ph.D, Principal Investigator, Affiliation: Gyeongsang University Hospital
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.
Clinical Details
Official title: Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Prevention rate of dexamethasone induced hiccup
Secondary outcome: Prevention rate of nausea and vomiting
Eligibility
Minimum age: 21 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gyeongsang University Hospital, Jinju, Korea, Republic of
Additional Information
Starting date: July 2010
Last updated: November 18, 2012
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