Methylprednisolone Replacement for Dexamethasone-induced Hiccup
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dexamethasone Hiccup |
Drug: Methylprednisolone |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients |
- Prevention rate of dexamethasone induced hiccup [ Time Frame: 24hrs after chemotherapy ] [ Designated as safety issue: Yes ]measure the presence of hiccup and its severity 24 hous after chemotherapy
- Prevention rate of nausea and vomiting [ Time Frame: acute; 24 hours, delayed; 7 days after chemotherapy ] [ Designated as safety issue: Yes ]Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively
| Enrollment: | 0 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methylprednisolone replacement
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
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Korea, Republic of | |
| Gyeongsang University Hospital | |
| Jinju, Korea, Republic of | |
| Principal Investigator: | Jung Hun Kang, M.D, Ph.D | Gyeongsang University Hospital |
More Information
No publications provided
| Responsible Party: | Jung Hun Kang, Associate Professor, Gyeongsang National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01277731 History of Changes |
| Other Study ID Numbers: | Gyeongsang-20100701 |
| Study First Received: | January 13, 2011 |
| Last Updated: | November 18, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Hiccup Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Dexamethasone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Dexamethasone 21-phosphate Prednisolone hemisuccinate Prednisolone phosphate BB 1101 Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013